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

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

Completed

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male or non-pregnant female ≥ 18 years-of-age with a clinical diagnosis of moderate facial rosacea;
Subjects had to have a definite clinical diagnosis of facial rosacea severity Grade 3 as per the IGE

Exclusion criteria

Female subjects who were pregnant, nursing, or planning to become pregnant during study participation;

Treatment and study plan

Azelaic Acid 15% topical gel

Drug

Gel

Other names: Azelaic Acid

Finacea® (azelaic acid) Gel, 15%

Drug

Gel

Other names: Azelaic Acid

Placebo

Drug

Gel

Other names: Vehicle

Primary outcomes

Change in inflammatory lesion counts

Time frame: 12 weeks

Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 29, 2017
Registry last updated: Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed