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NCT03094403 Clinical Trial

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

Rosacea Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03094403
Other study ID # AZAG 1533
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2016
Est. completion date April 1, 2017

Study information
Verified date April 2024
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date April 1, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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;

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Azelaic Acid 15% topical gel
Gel
• Finacea® (azelaic acid) Gel, 15%
Gel
• Placebo
Gel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Outcome
Type Measure Description Time frame Safety issue
Primary Change in inflammatory lesion counts Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts 12 weeks
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