<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/NCT03005964</url>
  </required_header>
  <id_info>
    <org_study_id>AD-AM001-001A</org_study_id>
    <nct_id>NCT03005964</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis</brief_title>
  <official_title>A Multi-Center, Double-Blind, Randomized, Vehicle- Controlled, Parallel-Group Study Comparing AM001 Cream, 7.5% to Vehicle Cream in the Treatment of Plaque Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AmDerma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Dermatology Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AmDerma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the&#xD;
      treatment of plaque psoriasis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">September 4, 2017</completion_date>
  <primary_completion_date type="Actual">August 15, 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigator's Global Assessment of Disease Severity (IGA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>An assessment of disease severity will be performed at each study visit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Psoriasis Area Severity Index (PASI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Surface Area (BSA)</measure>
    <time_frame>12 weeks</time_frame>
    <description>The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Area</measure>
    <time_frame>12 weeks</time_frame>
    <description>The target lesion area will be measured at baseline and each-post-baseline visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured at baseline and week 12</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Plaque Psoriasis</condition>
  <arm_group>
    <arm_group_label>AM001 Cream, 7.5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A white to off-white Cream free from any foreign particles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle Cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A white to off-white Cream free from any foreign particles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AM001 Cream, 7.5%</intervention_name>
    <description>Active Cream</description>
    <arm_group_label>AM001 Cream, 7.5%</arm_group_label>
    <other_name>Potassium Dobesilate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle Cream</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Vehicle Cream</arm_group_label>
    <other_name>Placebo Cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must provide written informed consent.&#xD;
&#xD;
          2. Subjects must be male or female, at least 18 years of age.&#xD;
&#xD;
          3. Subjects with a definite diagnosis of plaque psoriasis that is clinically active (for&#xD;
             at least 3 months), involving at least 10% and up to 20% of the body surface area (not&#xD;
             including the head [ scalp, face], hands, feet, and intertriginous areas).&#xD;
&#xD;
          4. Subjects with an Investigator's Global Assessment (IGA) of disease severity of at&#xD;
             least moderate severity (score ≥ 3) as an overall assessment.&#xD;
&#xD;
          5. Subjects with a target lesion which has the following characteristics:&#xD;
&#xD;
               1. located on the extremities (i.e., arms or legs ) and has an area of ≥25 cm2;&#xD;
&#xD;
               2. has a minimum plaque erythema of at least moderate severity (PASI grade ≥ 3);&#xD;
&#xD;
               3. has a minimum plaque scaling severity of at least moderate severity (PASI grade ≥&#xD;
                  3);&#xD;
&#xD;
               4. has a minimum plaque elevation of at least moderate severity (PASI grade ≥ 3);&#xD;
&#xD;
          6. If females of childbearing potential, the subject must have a negative urine pregnancy&#xD;
             test, and must have been using an acceptable form of birth control for at least two&#xD;
             months prior to Visit 1/Screening and are willing to continue birth control throughout&#xD;
             the study.&#xD;
&#xD;
          7. Subjects must be willing and able to understand and comply with the requirements of&#xD;
             the study, apply the assigned investigational product as instructed, return for the&#xD;
             required treatment period visits, comply with therapy prohibitions, and be able to&#xD;
             complete the study.&#xD;
&#xD;
          8. Subjects must be in good health, as confirmed by medical history and physical exam,&#xD;
             and free from any clinically significant disease/condition, other than plaque&#xD;
             psoriasis, that might interfere with the study evaluations.&#xD;
&#xD;
          9. Subjects must be willing to limit sun exposure overall. Subjects are prohibited from&#xD;
             sunbathing or intentional tanning or intense sun exposure including the use of tanning&#xD;
             booths/lights or other artificial UV light sources throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant, nursing, or planning a pregnancy within the study&#xD;
             participation period.&#xD;
&#xD;
          2. Subjects who have a current diagnosis of guttate, pustular, inverse, exfoliative, or&#xD;
             erythrodermic psoriasis.&#xD;
&#xD;
          3. Subjects who have a history of psoriasis unresponsive to topical treatments.&#xD;
&#xD;
          4. Subjects who have a history of a disorder that may interfere with the evaluation of&#xD;
             plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis,&#xD;
             cutaneous lymphoma, etc.).&#xD;
&#xD;
          5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment&#xD;
             areas, which could interfere with the rating of efficacy parameters.&#xD;
&#xD;
          6. Subjects with unstable medical disorders, life-threatening disease, or current&#xD;
             malignancies.&#xD;
&#xD;
          7. Subjects with clinically significant ECG or laboratory abnormalities at Visit&#xD;
             1/Screening (as determined by the Principal Investigator or designee).&#xD;
&#xD;
          8. Subjects who are immunosuppressed.&#xD;
&#xD;
          9. Subjects who have a history of allergy or a known hypersensitivity to any component of&#xD;
             the investigational product.&#xD;
&#xD;
         10. Subjects who have been treated with any systemic steroids within the 4 weeks prior to&#xD;
             the study entry (intranasal or inhaled corticosteroids are acceptable if kept constant&#xD;
             throughout the study, and intra-articular steroid injections are permissible).&#xD;
&#xD;
         11. Subjects who have been treated with systemic or photo antipsoriatic therapies/drugs&#xD;
             within 4 weeks prior to study entry including methotrexate, cyclosporine, acitretin&#xD;
             and other oral retinoids, broadband or narrowband UVB, PUVA, home or professional&#xD;
             tanning lights or other nonprescription UV light sources, photodynamic therapy (PDT),&#xD;
             lasers, mycophenalate mofetil (MMF), thioguanine, hydroxyurea, sirolimus,&#xD;
             azathioprine, 6-mercaptopurine (6-MP), or etanercept.&#xD;
&#xD;
         12. Subjects who have been treated with biologic therapy other than etanercept within 8&#xD;
             weeks prior to study entry, including adalibumab, infliximab, ustekinumab, golimumab,&#xD;
             or rituximab. Vaccines will not be considered an exclusionary biologic treatment.&#xD;
&#xD;
         13. Subjects treated with any other biologic agent not listed here for psoriasis or&#xD;
             psoriatic arthritis within 12 weeks.&#xD;
&#xD;
         14. Subjects who have been treated with any topical anti-psoriatic (e.g., salicylic acid,&#xD;
             anthralin, tar, etc.,) any topical corticosteroid medications, topical retinoids&#xD;
             (e.g., tazarotene, tretinoin), topical Vitamin D analogs (e.g., calcipotriene),&#xD;
             topical immunosuppressants (e.g., tacrolimus, pimecrolimus) within 2 weeks prior to&#xD;
             study entry.&#xD;
&#xD;
         15. Subjects who have been treated with lithium, antimalarial agents, or quinidine within&#xD;
             the 4 weeks prior to study entry.&#xD;
&#xD;
         16. Subjects who have received radiation therapy and/or anti-neoplastic agents, or taken&#xD;
             any immunosuppressant medication within 3 months prior to study entry.&#xD;
&#xD;
         17. Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition&#xD;
             that would compromise compliance, in the investigator's opinion, with this protocol.&#xD;
&#xD;
         18. Subjects who have been treated with an investigational drug or investigational device&#xD;
             within a period of 30 days prior to study entry, and within 120 days for&#xD;
             investigational biologic agent.&#xD;
&#xD;
         19. Subjects who have been previously enrolled in this study.&#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>Instituto Dermatogical y Cirugia de Piel</name>
      <address>
        <city>San Cristobal</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Dermatologico Blanco Falette, MD</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <disposition_first_submitted>October 1, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>October 1, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 3, 2018</disposition_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</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>Psoriasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03005964
org study id: AD-AM001-001A
nct id: NCT03005964
lead sponsor: 
collaborator: 
has dmc: No
To compare the safety and efficacy profiles of AM001 Cream, 7.5% and its vehicle cream in the
      treatment of plaque psoriasis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Investigator's Global Assessment of Disease Severity (IGA)
time frame: 12 weeks
description: An assessment of disease severity will be performed at each study visit
measure: Target Lesion Psoriasis Area Severity Index (PASI)
time frame: 12 weeks
description: Erythema, Scaling and Plaque Elevation of the target lesion will be scored at baseline and at each subsequent study visit.
measure: Body Surface Area (BSA)
time frame: 12 weeks
description: The % BSA of all treatable psoriatic lesions and regions will be recorded at baseline and at week 12.
measure: Target Lesion Area
time frame: 12 weeks
description: The target lesion area will be measured at baseline and each-post-baseline visit.
measure: Dermatology Life Quality Index (DLQI)
time frame: 12 weeks
description: Measured at baseline and week 12
arm group label: AM001 Cream, 7.5%
arm group type: Experimental
description: A white to off-white Cream free from any foreign particles
arm group label: Vehicle Cream
arm group type: Placebo Comparator
description: A white to off-white Cream free from any foreign particles.
intervention type: Drug
intervention name: AM001 Cream, 7.5%
description: Active Cream
arm group label: AM001 Cream, 7.5%
other name: Potassium Dobesilate
intervention type: Drug
intervention name: Vehicle Cream
description: Placebo
arm group label: Vehicle Cream
other name: Placebo Cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Dominican Republic
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No