<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/NCT03268174</url>
  </required_header>
  <id_info>
    <org_study_id>AOB-2016-AD</org_study_id>
    <nct_id>NCT03268174</nct_id>
  </id_info>
  <brief_title>Cosmetic Study to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.</brief_title>
  <official_title>A Placebo-Controlled, Double-Blind, Bilateral Cosmetic Study With an Open Label Extension to Evaluate the Performance of a Cosmetic Product Designed to Improve the Appearance of Skin Afflicted With Mild to Moderate Atopic Dermatitis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AOBiome LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on&#xD;
      the appearance of arm skin in subjects with atopic dermatitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, double-blind, bilateral, placebo-controlled study in subjects with&#xD;
      Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to&#xD;
      participate.&#xD;
&#xD;
      Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the&#xD;
      Baseline visit assessments, subjects will be asked to apply &quot;AO+ Mist&quot; or placebo to the&#xD;
      affected area of the arm twice a day (morning and night) for 30 days.&#xD;
&#xD;
      After the 30 day initial study period, subjects will automatically be rolled over to&#xD;
      participate in the extension of the trial for another 30 days using only AO+Mist on the body&#xD;
      parts affected by Atopic Dermatitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2016</start_date>
  <completion_date type="Actual">February 13, 2017</completion_date>
  <primary_completion_date type="Actual">February 13, 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>This is a bilateral study. Each subject will apply appropriately labeled test product to the left and right arm.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance</measure>
    <time_frame>Baseline-Day 30</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Atopic Dermatitis EASI score</measure>
    <time_frame>Baseline-Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Skindex16 Quality of Life survey</measure>
    <time_frame>Baseline-Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Skindex 16 Quality of Life Survey during Extension Period</measure>
    <time_frame>Day 30-60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in EASI score during Extension Period</measure>
    <time_frame>Day 30-60</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Atopic Dermatitis Eczema</condition>
  <arm_group>
    <arm_group_label>AO+Mist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AO+Mist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AO+Mist</intervention_name>
    <description>Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain &quot;AO+Mist&quot;.&#xD;
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:&#xD;
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.&#xD;
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.</description>
    <arm_group_label>AO+Mist</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain &quot;AO+Mist&quot;.&#xD;
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:&#xD;
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.&#xD;
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects ≥18&#xD;
&#xD;
          2. In good general health as determined by a thorough medical history i. Visible flexural&#xD;
             dermatitis ii. Personal history of flexural dermatitis iii. Personal history of dry&#xD;
             skin in the past 12 months&#xD;
&#xD;
          3. Subjects should have similar presentation and severity of AD on both arms&#xD;
&#xD;
          4. Ability to comprehend and comply with study procedures&#xD;
&#xD;
          5. Agree to commit to participate in the current protocol&#xD;
&#xD;
          6. Provide written informed consent prior to any study procedure being performed (all&#xD;
             subjects should be able to understand the informed consent form and any other&#xD;
             documents that subjects are required to read)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or lactating or who are trying to conceive&#xD;
&#xD;
          2. Any clinically relevant abnormality identified on the screening history or any other&#xD;
             medical condition or circumstance making the volunteer unsuitable for participation in&#xD;
             the study&#xD;
&#xD;
          3. Any skin condition which in the investigator's opinion may interfere with the&#xD;
             evaluation of Atopic Dermatitis&#xD;
&#xD;
          4. Severe cases of AD that present with pustules and weeping and those cases that require&#xD;
             urgent medical attention&#xD;
&#xD;
          5. Treatment with any investigational drug within 30 days or 5 half-lives (whichever is&#xD;
             longer) prior to the beginning of the screening period (this includes investigational&#xD;
             formulations of marketed products, inhaled and topical drugs)&#xD;
&#xD;
          6. Hypersensitivity to AO+Mist or its components&#xD;
&#xD;
          7. Seropositive for human immunodeficiency virus (HIV) by medical history review at&#xD;
             screening&#xD;
&#xD;
          8. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus&#xD;
             antibody (HCV Ab) by medical history review at screening&#xD;
&#xD;
          9. Any other condition and/or situation that causes the Investigator to deem a subject&#xD;
             unsuitable for the study (e.g., due to expected test product non-compliance, inability&#xD;
             to medically tolerate the study procedures, or a subject's unwillingness to comply&#xD;
             with study-related procedures)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical Dermatology Associates of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03268174
org study id: AOB-2016-AD
nct id: NCT03268174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to observe the performance of a cosmetic product, AO+Mist, on
      the appearance of arm skin in subjects with atopic dermatitis
This is a single center, double-blind, bilateral, placebo-controlled study in subjects with
      Atopic Dermatitis affecting both sides of the body. Up to 20 subjects will be enrolled to
      participate.

      Subjects will undergo a 2 week washout period prior to the Baseline procedure. Follwoing the
      Baseline visit assessments, subjects will be asked to apply "AO+ Mist" or placebo to the
      affected area of the arm twice a day (morning and night) for 30 days.

      After the 30 day initial study period, subjects will automatically be rolled over to
      participate in the extension of the trial for another 30 days using only AO+Mist on the body
      parts affected by Atopic Dermatitis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a bilateral study. Each subject will apply appropriately labeled test product to the left and right arm.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: AO+ Mist (or placebo) are supplied in white 100mL metered spray bottles. Test products are blinded and labeled for application to the LEFT or RIGHT side of the body
measure: Number of Participants With Treatment-Related Adverse Events as assessed by physical exam and appearance
time frame: Baseline-Day 30
measure: Difference in Atopic Dermatitis EASI score
time frame: Baseline-Day 30
measure: Difference in Skindex16 Quality of Life survey
time frame: Baseline-Day 30
measure: Difference in Skindex 16 Quality of Life Survey during Extension Period
time frame: Day 30-60
measure: Difference in EASI score during Extension Period
time frame: Day 30-60
arm group label: AO+Mist
arm group type: Active Comparator
description: AO+Mist
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Other
intervention name: AO+Mist
description: Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain "AO+Mist".
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
arm group label: AO+Mist
intervention type: Other
intervention name: Placebo
description: Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain "AO+Mist".
Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No