An international, multi-centre, prospective, randomised, double-blind, 4-arm, placebo controlled, parallel group study with 12 weeks once daily oral treatment in subjects with psoriasis vulgaris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Canada
Hôpital Saint-Louis, Service de Dermatologie
Paris, France
Percentage Change in Psoriasis Area and Severity Index (PASI)
The investigator made assessments of the extent and severity of clinical signs of the participant's psoriasis on specific areas of the body in terms of three clinical signs: redness, thickness and scaliness. The extent of psoriatic involvement was recorded for each of four areas; head, arms, trunk and legs using the following scale: 0\. = no involvement 1. = \<10% 2. = 10-29% 3. = 30-49% 4. = 50-69% 5. = 70-89% 6. = 90-100% For each clinical sign a single score (0, 1, 2, 3 or 4) reflecting the average severity of all psoriatic lesions on the given body region was determined. PASI was calculated based on the investigator's assessment of the disease locally (head, trunk, arm, legs) using the following formula: Head: 0.1 (R + T + S)E = W Arms: 0.2 (R + T + S)E = X Trunk: 0.3 (R + T + S)E = Y Legs: 0.4 (R + T + S)E = Z R = score for redness; T = score for thickness, S = score for scaliness; E = score for extent The sum of W+X+Y+Z gives the total PASI that ranges from 0 to 72.
Time frame: Baseline (Day 0) to end of treatment (Day 84)
Participants With at Least 75% Reduction in PASI (PASI 75)
Time frame: From baseline (Day 0) to end of treatment (Day 84)
Participants With at Least 50% Reduction in PASI (PASI 50)
Time frame: From baseline (Day 0) to end of treatment (Day 84)
Participants With "Controlled Disease" According to the Investigators' Global Assessment (IGA)
At Visits 1 to 8 the investigator made a global assessment of the disease severity (IGA) using a 6-point scale (clear, almost clear, mild, moderate, severe, very severe). This assessment represents average lesion severity on head, trunk, arm and legs. The assessment was based on the condition of the disease at the time of evaluation and not in relation to the condition at a previous visit. Participants classified as clear or almost clear according to IGA was considered to have "controlled disease".
Time frame: At end of treatment (Day 84)
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Participants With Satisfactory Response According to IGA
"Satisfactory response" was defined as participants classified as "Clear" or "Almost Clear" or "Mild" according to the IGA.
Time frame: At end of treatment (Day 84)