NCT02005666

To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel

A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC® Gel (of Stiefel Laboratories, USA) Versus Placebo (Vehicle Gel) in the Ratio of 2:2:1 Respectively, in Patients With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Zydus Lifesciences Limited · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel	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
DRUG	DUAC® Gel	Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
DRUG	Placebo	Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-09-28
• Completion: 2016-09-28
• First posted: 2013-12-09
• Last updated: 2020-10-14
• Results posted: 2020-09-14

Locations

36 sites across 2 countries: United States, India