MILD TO SEVERE ACNE VULGARIS Clinical Trial
Official title:
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY COMPARING CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL (ACTAVIS MID-ATLANTIC LLC) TO ZIANA® (CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%) GEL (MEDICIS, THE DERMATOLOGY COMPANY®) AND BOTH ACTIVE TREATMENTS TO CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL PLACEBO (ACTAVIS MID-ATLANTIC LLC) IN THE TREATMENT OF MILD TO SEVERE ACNE VULGARIS
ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to evaluate the bioequivalence of this formulation to ZIANA®.
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment