Psoriasis Clinical Trial
Official title:
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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