This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
699
Psoriasis Area Severity Index (PASI)
To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
Time frame: at Day 1, Day 28
Physician Global Assessment (PGA)
To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
Time frame: at Day 1, Day 28
Body Surface Area (BSA)
To evaluate the total body area of skin affected by psoriasis.
Time frame: at Day 1
Adverse Events and Serious Adverse Events
Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis
Time frame: at Day 28
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