Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
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.
|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|
- 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.
- PASI reduction of 50% [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
|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)|
A concentration of 0.025% of topical DD-25 cream.
A topical DD-25 cream at 0.025% concentration.
Other Name: Fortuderm DD-25 Psoriasis Cream
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.
|Contact: Avi Dascalu, M.D., Ph.D.||email@example.com|
|Tel Aviv Sourasky Medical Center||Recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Dvora Krulfeld, M.A. 97236973768 firstname.lastname@example.org|
|Principal Investigator: Hagit Matz, M.D.|
|Principal Investigator:||Hagit Matz, M.D.||Dept of Dermatology, Tel Aviv Sourasky Medical Center|