Conditions: Acne Vulgaris
Keywords: Acne Vulgaris DUAC CADILA CLIANTHA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 850
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days arm 2: Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days arm 3: Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Interventions: intervention 1: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel intervention 2: DUAC® Gel intervention 3: Placebo
Intervention descriptions: intervention 1: Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days intervention 2: Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days intervention 3: Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Protocol document: