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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001.
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.
Time frame: 84 days
Change in PASI score from baseline (Day 0) to Day 84 for patients in Group 1 compared with those in Group 2.
Change in the Psoriasis Area and Severity Index (PASI) score from the baseline (Day 0) at Day 84 in patients randomized to the placebo compared with those randomized to the 1.0% WBI-1001 cream treatment.
Time frame: 84 days
Blood and urine analyses and vital signs assessments of patients from Day 0 to Day 84, and the follow-up at Day 112.
Comparative assessment of the laboratory analyses and vital signs of Group 1 and Group 2 patients from Day 0 to Day 84, and the follow-up at Day 112.
Time frame: 84 days plus 112 day follow-up.
Change from baseline in BSA at Day 84 in patients randomized to placebo compared with those randomized to 1.0% WBI-1001 cream treatment.
Change in the BSA of involved skin (except for the face, scalp, groin and genital areas) from that at baseline (Day 0) to that at Day 84 when comparing patients in Group 1 with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0) in mean target lesion score at Day 84 in patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0)in target lesion induration at Day 84 in patients in Group 1 compared with those in Group 2.
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Time frame: 84 days
Change from baseline (Day 0) in target lesion scaling at Day 84 in patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0)in target lesion erythema at Day 84 in patients from Group 1 compared with those from Group 2.
Time frame: 84 days
Type, frequency, severity and relationship of adverse events in patients from Group 1 compared with those from Group 2.
Time frame: 84 days + follow-up at 112 days