<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/NCT01702324</url>
  </required_header>
  <id_info>
    <org_study_id>DD-25</org_study_id>
    <secondary_id>0290-12-TLV</secondary_id>
    <nct_id>NCT01702324</nct_id>
  </id_info>
  <brief_title>Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study</brief_title>
  <official_title>Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fortuderm Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fortuderm Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on&#xD;
      plaque Psoriasis Vulgaris.&#xD;
&#xD;
      The study will include subjects at plaque stage from 5-20% body area involvement. A total of&#xD;
      30 subjects will be treated with cream application on affected areas twice daily for three&#xD;
      weeks.The efficacy of the preparation will be documented by PASI score, Global physician&#xD;
      assessment and photos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriasis Vulgaris remains a widespread clinical entity with chronic outflares and various&#xD;
      regimens of treatment, none of them definitive. A new safe and efficacious, external&#xD;
      treatment is required for.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy after 3 weeks as compared to baseline.</measure>
    <time_frame>3 weeks</time_frame>
    <description>Evaluation of the effectiveness of DD-25 over a period of 3 weeks treatment by analyzing the changes in the Psoriasis Area &amp; Severity Index (PASI) in moderate to mild Plaque Psoriasis patients. Improvement to be assessed by changes in erythema, induration and desquamation as seen on days 0, 10 and 21.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PASI reduction of 50%</measure>
    <time_frame>3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <arm_group>
    <arm_group_label>DD-25</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A concentration of 0.025% of topical DD-25 cream.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DD-25</intervention_name>
    <description>A topical DD-25 cream at 0.025% concentration.</description>
    <arm_group_label>DD-25</arm_group_label>
    <other_name>Fortuderm DD-25 Psoriasis Cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject age 18-60&#xD;
&#xD;
          2. Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk&#xD;
&#xD;
          3. Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.&#xD;
&#xD;
          4. Subject understood and signed an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form&#xD;
             of psoriasis.&#xD;
&#xD;
          2. Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be&#xD;
             worsened by UV light exposure&#xD;
&#xD;
          3. Pregnancy, breast feeding&#xD;
&#xD;
          4. History of cancer, excluding non-melanoma skin cancer.&#xD;
&#xD;
          5. Patients with history of ischemic heart disease (e.g. angina pectoris, myocardial&#xD;
             infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled&#xD;
             hypertension. Subjects with known severe hepatic and/or severe renal insufficiency.&#xD;
&#xD;
          6. Any medical condition that, in the opinion of the Investigator, would jeopardize the&#xD;
             health of the patient during the course of this study.&#xD;
&#xD;
          7. Systemic treatment with biological therapies with a possible effect on psoriasis&#xD;
             vulgaris within 4 months or 5 drug half-lives prior to checkup.&#xD;
&#xD;
          8. Systemic treatments with all other therapies than biologicals, with a potential effect&#xD;
             on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids,&#xD;
             immuno-suppressants) within the 8-week period prior to randomization. Subjects using&#xD;
             within the 8 week period prior to randomization PUVA or Phototherapy. Use of SSRI or&#xD;
             MAO inhibitors.&#xD;
&#xD;
          9. Subjects using one of the following TOPICAL drugs for the treatment of PS within 2&#xD;
             weeks prior to randomization: e.g. WHO group I-II corticosteroids, retinoids, Vit. D&#xD;
             analogues, immunomodulators, Anthracene derivatives, Salicylic acid.&#xD;
&#xD;
         10. Subjects with current participation in any other interventional clinical or subjects&#xD;
             with any concomitant dermatological disorder(s) which might preclude accurate&#xD;
             evaluation of the psoriasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hagit Matz, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Dermatology, Tel Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Avi Dascalu, M.D., Ph.D.</last_name>
    <phone>972-3-6099005</phone>
    <email>dasc01@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dvora Krulfeld, M.A.</last_name>
      <phone>97236973768</phone>
      <email>dvoray@tasmc.health.gov.il</email>
    </contact>
    <investigator>
      <last_name>Hagit Matz, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis Vulgaris</keyword>
  <keyword>Plaque</keyword>
  <keyword>Topical</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01702324
org study id: DD-25
secondary id: 0290-12-TLV
nct id: NCT01702324
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on
      plaque Psoriasis Vulgaris.

      The study will include subjects at plaque stage from 5-20% body area involvement. A total of
      30 subjects will be treated with cream application on affected areas twice daily for three
      weeks.The efficacy of the preparation will be documented by PASI score, Global physician
      assessment and photos.
Psoriasis Vulgaris remains a widespread clinical entity with chronic outflares and various
      regimens of treatment, none of them definitive. A new safe and efficacious, external
      treatment is required for.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy after 3 weeks as compared to baseline.
time frame: 3 weeks
description: Evaluation of the effectiveness of DD-25 over a period of 3 weeks treatment by analyzing the changes in the Psoriasis Area & Severity Index (PASI) in moderate to mild Plaque Psoriasis patients. Improvement to be assessed by changes in erythema, induration and desquamation as seen on days 0, 10 and 21.
measure: PASI reduction of 50%
time frame: 3 weeks
arm group label: DD-25
arm group type: Experimental
description: A concentration of 0.025% of topical DD-25 cream.
intervention type: Drug
intervention name: DD-25
description: A topical DD-25 cream at 0.025% concentration.
arm group label: DD-25
other name: Fortuderm DD-25 Psoriasis Cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hagit Matz, M.D.
role: Principal Investigator
affiliation: Dept of Dermatology, Tel Aviv Sourasky Medical Center
last name: Avi Dascalu, M.D., Ph.D.
phone: 972-3-6099005
email: dasc01@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Psoriasis