To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Status:
Completed
Trial end date:
2016-09-28
Target enrollment:
Participant gender:
Summary
This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo
Controlled, Three Arm Clinical Study.
The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate
1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of
Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo
respectively.
Total study duration will be for a period of 78 days which includes treatment duration of 77
days.
850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria
mentioned in the protocol.