NCT01098721

A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Welichem Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A double-blinded, placebo-controlled study. Following screening, eligible patients will be randomized on Day 0 into one of two treatment groups in a 1:2 ratio: Group 1: placebo (vehicle) cream, twice daily (BID). Group 2: 1.0% WBI-1001 cream, BID. Patients will be randomized to treat all treatable lesion areas except for the face, scalp, groin and genital areas, and will be instructed to apply the cream twice daily for 84 days, at the same time each day, once in the morning and once in the evening. During the study patients will visit the study centre for assessment of efficacy, safety and tolerability at 0, 14, 28, 56 and 84 days after initiation, and patients will be phoned at Day 112 for a follow-up safety assessment. Patients that withdraw from the study before Day 56 due to reasons other than adverse events will be replaced as necessary to ensure that there are at least 16 patients from the placebo and 32 from the active cream treated groups remaining in the study at Day 56.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	WBI-1001	Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2010-04-05
• Last updated: 2012-12-20