NCT04015375

Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multi-center,Double-blind,Randomized,Three-arm,Placebo-controlled,Parallel-group Study, Comparing Dapsone Gel,7.5% (Torrent Pharma) to Aczone® Gel,7.5% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Torrent Pharmaceuticals Limited · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne vulgaris.

Detailed description

A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)	Topical gel
DRUG	ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)	Topical gel
OTHER	Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)	Topical gel

Timeline

• Start date: 2019-07-11
• Primary completion: 2020-02-03
• Completion: 2020-02-22
• First posted: 2019-07-11
• Last updated: 2020-04-02

Locations

13 sites across 2 countries: United States, Belize

Regulatory

• FDA-regulated drug study