NCT03094403

To Evaluate the Therapeutic Equivalence and Safety of Azelaic Acid 15% Topical Gel

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study

Detailed description

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, comparing AZELAIC ACID TOPICAL GEL 15% TO FINACEA® and both active treatments to a Placebo Control in the treatment of Moderate of Facial Rosacea.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Azelaic Acid 15% topical gel	Gel
DRUG	Finacea® (azelaic acid) Gel, 15%	Gel
DRUG	Placebo	Gel

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-31
• Completion: 2017-04-01
• First posted: 2017-03-29
• Last updated: 2024-04-10

Regulatory

• FDA-regulated drug study