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



Status:Completed
Conditions:Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:5/5/2017
Start Date:July 1, 2016
End Date:April 1, 2017

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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.

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

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;
We found this trial at
1
site
Hawthorne, New York 10532
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from
Hawthorne, NY
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