Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Fortuderm Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fortuderm Ltd.
ClinicalTrials.gov Identifier:
NCT01702324
First received: October 3, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Psoriasis Vulgaris
Drug: DD-25
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by Fortuderm Ltd.:

Primary Outcome Measures:
  • Efficacy after 3 weeks as compared to baseline. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PASI reduction of 50% [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DD-25
A concentration of 0.025% of topical DD-25 cream.
Drug: DD-25
A topical DD-25 cream at 0.025% concentration.
Other Name: Fortuderm DD-25 Psoriasis Cream

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject age 18-60
  2. Diagnosis of PS by a dermatologist with lesions on arms, legs or trunk
  3. Subjects have stable plaque PS, mild to moderate form, Body Surface Area of 5-20%.
  4. Subject understood and signed an informed consent form

Exclusion Criteria:

  1. Guttate, erythrodermic, palm-plantar or pustular psoriasis as sole or predominant form of psoriasis.
  2. Hypersensitivity to sunlight; history of Lupus, PMLE, or any disease known to be worsened by UV light exposure
  3. Pregnancy, breast feeding
  4. History of cancer, excluding non-melanoma skin cancer.
  5. Patients with history of ischemic heart disease (e.g. angina pectoris, myocardial infarction); cerebrovascular syndromes, peripheral vascular or uncontrolled hypertension. Subjects with known severe hepatic and/or severe renal insufficiency.
  6. Any medical condition that, in the opinion of the Investigator, would jeopardize the health of the patient during the course of this study.
  7. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within 4 months or 5 drug half-lives prior to checkup.
  8. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 8-week period prior to randomization. Subjects using within the 8 week period prior to randomization PUVA or Phototherapy. Use of SSRI or MAO inhibitors.
  9. Subjects using one of the following TOPICAL drugs for the treatment of PS within 2 weeks prior to randomization: e.g. WHO group I-II corticosteroids, retinoids, Vit. D analogues, immunomodulators, Anthracene derivatives, Salicylic acid.
  10. Subjects with current participation in any other interventional clinical or subjects with any concomitant dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702324

Contacts
Contact: Avi Dascalu, M.D., Ph.D. 972-3-6099005 dasc01@yahoo.com

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Dvora Krulfeld, M.A.    97236973768    dvoray@tasmc.health.gov.il   
Principal Investigator: Hagit Matz, M.D.         
Sponsors and Collaborators
Fortuderm Ltd.
Investigators
Principal Investigator: Hagit Matz, M.D. Dept of Dermatology, Tel Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Fortuderm Ltd.
ClinicalTrials.gov Identifier: NCT01702324     History of Changes
Other Study ID Numbers: DD-25, 0290-12-TLV
Study First Received: October 3, 2012
Last Updated: October 4, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Fortuderm Ltd.:
Psoriasis Vulgaris
Plaque
Topical
Treatment

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 19, 2014