A Double-blinded, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Topically Applied 1.0% WBI-1001 Cream for 12 Weeks, in the Treatment of Mild to Moderate Plaque Psoriasis. (134993)

NCT01098721 Phase 2 COMPLETED

Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This study, in patients with mild to moderate plaque psoriasis, is designed to further determine the efficacy, safety and tolerability of the novel, topically applied, non-steroid, anti-inflammatory WBI-1001 cream over a period of 12 weeks.

Details

Lead sponsor	Welichem Biotech Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	61
Start date	2010-01
Completion	2010-11

Conditions

• Psoriasis

Interventions

• WBI-1001

Primary outcomes

• Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001. — 84 days
  The primary indication of efficacy will be demonstrated by improvement in the Physician's Global Assessment (PGA) in patients treated with the active (1.0% WBI-1001) cream as compared with those treated with the placebo cream.