NCT03689010

To Evaluate the Therapeutic Equivalence and Safety in Treatment of Moderate Facial Rosacea

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,116 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

Detailed description

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study, comparing test and reference products and both active treatments to a placebo control in the treatment of Moderate Facial Rosacea.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Azelaic acid foam 15%	Azelaic acid foam 15%
DRUG	Finacea® (Azelaic acid Foam) 15%	Azelaic acid foam 15%
DRUG	Vehicle of the test product	Vehicle of the test product

Timeline

• Start date: 2017-12-12
• Primary completion: 2018-08-09
• Completion: 2018-09-28
• First posted: 2018-09-28
• Last updated: 2019-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study