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

Sun Pharmaceutical Industries, Inc.1,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,000

Conditions

Rosacea

Interventions

Azelaic Acid 15% topical gelDRUG

Gel

Finacea® (azelaic acid) Gel, 15%DRUG

Gel

PlaceboDRUG

Gel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Change in inflammatory lesion counts

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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