NCT04134273

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,260 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Detailed description

The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	CLPG Topical Gel 1%	Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)
DRUG	Clindamycin	Clindamycin Phosphate topical gel 1%
DRUG	Placebo	Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-09-17
• Completion: 2019-10-15
• First posted: 2019-10-22
• Last updated: 2019-10-22

Locations

1 site across 1 country: United States