Efficacy and Safety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic Plaque Psoriasis
The primary objective of this study will be to evaluate the efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
The secondary objective will be to evaluate the safety of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects.
Tertiary objectives will be to provide visual documentation of the improvement of psoriatic plaques treated with ALT-2074 using digital photography, and to determine the extent of systemic absorption of topically applied ALT-2074 based on a pharmacokinetic measurement of blood concentration.
|Psoriasis||Drug: 4,4-dimethyl-benziso-2H-selenazine Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Wafety of Topical ALT-2074 (SYI-2074) for Treatment of Chronic|
- Efficacy of topical ALT-2074 applied twice daily for 28 days for treatment of chronic plaque psoriasis in adult subjects. [ Time Frame: 28 days ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||March 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Two psoriatic plaques of similar surface area and severity will be identified for each subject. ALT-2074 will be applied topically twice daily to 1 of the 2 target plaques, and the placebo control to the other plaque for a period of 28 days in amounts sufficient to cover the entire surface area of the target plaque, extending to 1 cm outside of the plaque border.
ALT-2074 in a 0.5% cream formulation
Placebo Comparator: 2
Placebo in a cream formulation
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782613
|Ha'emek Medical Center|
|Kaplan Medical Center|
|Chaim Sheba Medical Center|
|Tel Hashomer, Israel|