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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Fortuderm Ltd..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01702324
First Posted: October 8, 2012
Last Update Posted: October 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fortuderm Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fortuderm Ltd.
ClinicalTrials.gov Identifier: NCT01702324     History of Changes
Other Study ID Numbers: DD-25
0290-12-TLV ( Other Identifier: Tel Aviv Sourasky Medical Center )
First Submitted: October 3, 2012
First Posted: October 8, 2012
Last Update Posted: October 8, 2012
Last Verified: October 2012

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

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