A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.

Official Title
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A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis

Conditions
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Perioral Dermatitis

Intervention / Treatment
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* Drug: Azelaic acid 15% gel
* Drug: Non-active base from azelaic acid 15% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4) 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles) Exclusion Criteria: History of atopic dermatitis of the face Granulomatous perioral dermatitis Facial acne, rosacea, facial demodicosis Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus The use of topical or systemic medications that could affect the course of treatment and/or evaluation Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes) Use of fluorinated toothpaste Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study History of or suspected hypersensitivity to any ingredient of the study drugs Participation in another clinical study 4 weeks prior to and/or during the conduct of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azelaic acid 15% Gel<br>Azelaic acid 15% | Drug: Azelaic acid 15% gel<br>* gel, applied once daily, for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Non-active base from Azelaic acid 15% gel | Drug: Non-active base from azelaic acid 15% gel<br>* gel, apply once daily for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sum score derived from the most important signs and symptoms of perioral dermatitis |  | Measurements and observations during the course of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of single signs and symptoms |  | Measured at scheduled visits during the course of the study | 
| Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator |  | Safety parameters recorded at scheduled visits during the course of the study |