NCT02929719

Study Comparing Test to Aczone 5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Test Gel, 5% to ACZONE Gel, 5% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,134 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Therapeutic equivalence and safety study

Detailed description

To evaluate the therapeutic equivalence and safety of Test formulation and marketed Reference Listed Drug (RLD). To demonstrate the superiority of efficacy of the Test and Reference products over the placebo control in the treatment. To compare the safety of Test, Reference and Placebo treatments.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Test.	gel
DRUG	Aczone Gel 5%	gel
DRUG	Placebo	gel

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-10-11
• Last updated: 2017-05-04