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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects in this randomized, double-blind, placebo controlled, parallel-group, multiple-center study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Azelaic Acid 15% topical gel

Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face

Group Type EXPERIMENTAL

Azelaic Acid 15% topical gel

Intervention Type DRUG

Gel

Finacea® (azelaic acid) Gel, 15%

Topical, twice daily, for 84 days A thin layer of study treatment was gently massaged into the affected areas on the face

Group Type ACTIVE_COMPARATOR

Finacea® (azelaic acid) Gel, 15%

Intervention Type DRUG

Gel

Placebo

Topically to the face, twice a day A thin layer of study treatment was gently massaged into the affected areas on the face

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Gel

Interventions

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Azelaic Acid 15% topical gel

Gel

Intervention Type DRUG

Finacea® (azelaic acid) Gel, 15%

Gel

Intervention Type DRUG

Placebo

Gel

Intervention Type DRUG

Other Intervention Names

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Azelaic Acid Azelaic Acid Vehicle

Eligibility Criteria

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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