<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02211417</url>
  </required_header>
  <id_info>
    <org_study_id>DS107G-02</org_study_id>
    <nct_id>NCT02211417</nct_id>
  </id_info>
  <brief_title>Oral DS107 in Moderate to Severe Atopic Dermatitis</brief_title>
  <official_title>A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dignity Sciences Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dignity Sciences Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients&#xD;
      with moderate to severe atopic dermatitis.&#xD;
&#xD;
      Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against&#xD;
      placebo.&#xD;
&#xD;
      This study will enroll approximately 100 adult patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week&#xD;
      8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable&#xD;
      will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global&#xD;
      Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body&#xD;
      Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality&#xD;
      Index).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.</measure>
    <time_frame>Week 8</time_frame>
    <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in IGA at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = no symptoms&#xD;
1 = slight&#xD;
2 = moderate&#xD;
3 = marked&#xD;
A decrease in EASI score indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.</measure>
    <time_frame>Up to 8 weeks.</time_frame>
    <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale:&#xD;
No Days = 0&#xD;
1-2 Days = 1&#xD;
3-4 Days = 2&#xD;
5-6 Days = 3&#xD;
Everyday = 4&#xD;
POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema.&#xD;
Lower scores on the scale represent a better outcome for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.</measure>
    <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
    <description>One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs in Each Treatment Group</measure>
    <time_frame>Up to 14 weeks</time_frame>
    <description>Number of participants with at least 1 TEAE.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Oral DS107 2g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules matching Oral DS107 capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral DS107</intervention_name>
    <arm_group_label>Oral DS107 2g</arm_group_label>
    <other_name>DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject aged 18 years and older.&#xD;
&#xD;
          -  Moderate to severe atopic dermatitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant impairment of renal or hepatic function.&#xD;
&#xD;
          -  History of hypersensitivity to any substance in Oral DS107 or placebo capsules.&#xD;
&#xD;
          -  Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).&#xD;
&#xD;
          -  Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources&#xD;
             and/or is planning a trip to sunny climate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Climax, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Dignity Sciences Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>West Dundee</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Verona</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Drummondville</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dignity Sciences investigational site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Scollan ND, Choi NJ, Kurt E, Fisher AV, Enser M, Wood JD. Manipulating the fatty acid composition of muscle and adipose tissue in beef cattle. Br J Nutr. 2001 Jan;85(1):115-24. doi: 10.1079/bjn2000223.</citation>
    <PMID>11227040</PMID>
  </reference>
  <reference>
    <citation>Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9.</citation>
    <PMID>19275928</PMID>
  </reference>
  <reference>
    <citation>Makrides M, Simmer K, Neumann M, Gibson R. Changes in the polyunsaturated fatty acids of breast milk from mothers of full-term infants over 30 wk of lactation. Am J Clin Nutr. 1995 Jun;61(6):1231-3. doi: 10.1093/ajcn/61.6.1231.</citation>
    <PMID>7762522</PMID>
  </reference>
  <reference>
    <citation>Teraoka N, Kawashima H, Shiraishi-Tateishi A, Tanaka T, Nakamura J, Kakutani S, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid-enriched oil altered serum fatty acids in healthy men. Biosci Biotechnol Biochem. 2009 Jun;73(6):1453-5. doi: 10.1271/bbb.90112. Epub 2009 Jun 7.</citation>
    <PMID>19502748</PMID>
  </reference>
  <reference>
    <citation>Tanaka T, Kakutani S, Horikawa C, Kawashima H, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid (DGLA)-enriched oil increases serum DGLA content in healthy adults. Lipids. 2012 Jun;47(6):643-6. doi: 10.1007/s11745-012-3664-3. Epub 2012 Mar 14.</citation>
    <PMID>22411689</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <results_first_submitted>August 3, 2022</results_first_submitted>
  <results_first_submitted_qc>September 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2022</results_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Evening primrose oil</mesh_term>
    <mesh_term>Mineral Oil</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 22, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT02211417/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT02211417/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in 2 countries at 17 sites.</recruitment_details>
      <pre_assignment_details>A total of 102 patients were randomised. Patients were randomised (1:1) at baseline visit to either receive Oral DS107 capsules (2 g) or Placebo once daily for 8 weeks in a fasting state (minimum 8 hour fast).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo capsules matching Oral DS107 capsules</description>
        </group>
        <group group_id="P2">
          <title>Oral DS107 2g</title>
          <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population - The safety population was defined as all randomised patients who received at least one dose of the medication. Analysis was done according to the actual treatment patients received.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo capsules matching Oral DS107 capsules</description>
        </group>
        <group group_id="B2">
          <title>Oral DS107 2g</title>
          <description>Oral DS107 2g, 4 x 500mg capsules administered orally once a day</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.9" spread="15.7"/>
                    <measurement group_id="B2" value="35.7" spread="13.6"/>
                    <measurement group_id="B3" value="39.8" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.</title>
        <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
        <time_frame>Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.</title>
          <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12"/>
                    <measurement group_id="O2" value="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.057</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in IGA at Week 2, 4 and 8.</title>
        <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IGA at Week 2, 4 and 8.</title>
          <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.4"/>
                    <measurement group_id="O2" value="-0.4" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.6"/>
                    <measurement group_id="O2" value="-0.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.8"/>
                    <measurement group_id="O2" value="-1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.</title>
        <description>EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = no symptoms&#xD;
1 = slight&#xD;
2 = moderate&#xD;
3 = marked&#xD;
A decrease in EASI score indicates a positive outcome for the participant.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>DS107G</title>
            <description>Oral DS107 2g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.</title>
          <description>EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = no symptoms&#xD;
1 = slight&#xD;
2 = moderate&#xD;
3 = marked&#xD;
A decrease in EASI score indicates a positive outcome for the participant.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="3.6"/>
                    <measurement group_id="O2" value="-2.8" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" spread="7.9"/>
                    <measurement group_id="O2" value="-7.2" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="9.5"/>
                    <measurement group_id="O2" value="-9.4" spread="11.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.</title>
        <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
        <time_frame>Up to 8 weeks.</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.</title>
          <description>The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43"/>
                    <measurement group_id="O2" value="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.</title>
        <description>The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale:&#xD;
No Days = 0&#xD;
1-2 Days = 1&#xD;
3-4 Days = 2&#xD;
5-6 Days = 3&#xD;
Everyday = 4&#xD;
POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema.&#xD;
Lower scores on the scale represent a better outcome for the patient.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.</title>
          <description>The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale:&#xD;
No Days = 0&#xD;
1-2 Days = 1&#xD;
3-4 Days = 2&#xD;
5-6 Days = 3&#xD;
Everyday = 4&#xD;
POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema.&#xD;
Lower scores on the scale represent a better outcome for the patient.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="5.6"/>
                    <measurement group_id="O2" value="-5.0" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="6.5"/>
                    <measurement group_id="O2" value="-6.9" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="7.7"/>
                    <measurement group_id="O2" value="-5.7" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.</title>
        <description>The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.</title>
          <description>The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="5.5"/>
                    <measurement group_id="O2" value="-4.2" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="6.0"/>
                    <measurement group_id="O2" value="-6.5" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="5.5"/>
                    <measurement group_id="O2" value="-5.5" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.</title>
        <description>The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.</title>
          <description>The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="8.7"/>
                    <measurement group_id="O2" value="-6.6" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.6" spread="14.7"/>
                    <measurement group_id="O2" value="-16.7" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.3" spread="18.4"/>
                    <measurement group_id="O2" value="-21.1" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.</title>
        <description>The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.</title>
          <description>The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.1"/>
                    <measurement group_id="O2" value="-1.6" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="2.7"/>
                    <measurement group_id="O2" value="-2.8" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" spread="3.3"/>
                    <measurement group_id="O2" value="-2.8" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.</title>
        <description>One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.</description>
        <time_frame>Baseline, Week 2, Week 4 and Week 8</time_frame>
        <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.</title>
          <description>One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.</description>
          <population>ITT Population - The Intent-to-treat (ITT) population consisted of all randomised patients. Analysis was done according to the randomised treatment. This population was used for all efficacy analyses</population>
          <units>percentage of BSA</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="4.9"/>
                    <measurement group_id="O2" value="-1.3" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="7.1"/>
                    <measurement group_id="O2" value="-5.2" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.0" spread="9.6"/>
                    <measurement group_id="O2" value="-9.6" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs in Each Treatment Group</title>
        <description>Number of participants with at least 1 TEAE.</description>
        <time_frame>Up to 14 weeks</time_frame>
        <population>The safety population was defined as all randomised patients who received at least one dose of the medication. Analysis was done according to the actual treatment patients received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsules matching Oral DS107 capsules</description>
          </group>
          <group group_id="O2">
            <title>Oral DS107 2g</title>
            <description>Oral DS1072g, 4 x 500mg capsules administered orally once a day</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs in Each Treatment Group</title>
          <description>Number of participants with at least 1 TEAE.</description>
          <population>The safety population was defined as all randomised patients who received at least one dose of the medication. Analysis was done according to the actual treatment patients received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 14 weeks.</time_frame>
      <desc>An adverse event was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship with this treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo capsules matching Oral DS107 capsules.</description>
        </group>
        <group group_id="E2">
          <title>Oral DS107 2g</title>
          <description>Oral DS107 2g, 4 x 500mg capsules administered orally once a day</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Anal Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Faeces Discoloured</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Faeces Soft</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal Allergy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Skin Bacterial Infections</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated Partial Thromboplastin Time Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Blood Test Abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Restless Leg Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Premenstrual Cramps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Dignity Sciences Ltd</organization>
      <phone>+353 1 2933590</phone>
      <email>dsbiopharma.regulatory@dsbiopharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211417
org study id: DS107G-02
nct id: NCT02211417
lead sponsor: 
has dmc: No
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients
      with moderate to severe atopic dermatitis.

      Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against
      placebo.

      This study will enroll approximately 100 adult patients.
Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week
      8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable
      will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global
      Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body
      Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality
      Index).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
time frame: Week 8
description: The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
measure: Change From Baseline in IGA at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
measure: Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
0 = no symptoms
1 = slight
2 = moderate
3 = marked
A decrease in EASI score indicates a positive outcome for the participant.
measure: Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
time frame: Up to 8 weeks.
description: The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
measure: Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale:
No Days = 0
1-2 Days = 1
3-4 Days = 2
5-6 Days = 3
Everyday = 4
POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema.
Lower scores on the scale represent a better outcome for the patient.
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
measure: Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:
0 = No symptoms
1 = Mild
2 = Moderate
3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.
measure: Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.
measure: Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
time frame: Baseline, Week 2, Week 4 and Week 8
description: One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.
measure: Number of Participants With TEAEs in Each Treatment Group
time frame: Up to 14 weeks
description: Number of participants with at least 1 TEAE.
arm group label: Oral DS107 2g
arm group type: Experimental
description: Oral DS1072g, 4 x 500mg capsules administered orally once a day
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules matching Oral DS107 capsules
intervention type: Drug
intervention name: Oral DS107
arm group label: Oral DS107 2g
other name: DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
other name: Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Climax, Ph.D.
role: Study Chair
affiliation: Dignity Sciences Ltd.
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country: Canada
country: United States
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PMID: 11227040
citation: Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9.
PMID: 19275928
citation: Makrides M, Simmer K, Neumann M, Gibson R. Changes in the polyunsaturated fatty acids of breast milk from mothers of full-term infants over 30 wk of lactation. Am J Clin Nutr. 1995 Jun;61(6):1231-3. doi: 10.1093/ajcn/61.6.1231.
PMID: 7762522
citation: Teraoka N, Kawashima H, Shiraishi-Tateishi A, Tanaka T, Nakamura J, Kakutani S, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid-enriched oil altered serum fatty acids in healthy men. Biosci Biotechnol Biochem. 2009 Jun;73(6):1453-5. doi: 10.1271/bbb.90112. Epub 2009 Jun 7.
PMID: 19502748
citation: Tanaka T, Kakutani S, Horikawa C, Kawashima H, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid (DGLA)-enriched oil increases serum DGLA content in healthy adults. Lipids. 2012 Jun;47(6):643-6. doi: 10.1007/s11745-012-3664-3. Epub 2012 Mar 14.
PMID: 22411689
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Evening primrose oil
mesh term: Mineral Oil
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