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

Phase 2

Completed

• Conditions: Perioral Dermatitis
• Interventions: Drug: Azelaic acid 15% gel; Drug: Non-active base from azelaic acid 15% gel

• Registration Number: NCT00403949
• Lead Sponsor: LEO Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-23
• Study First Submitted QC: 2006-11-23
• Study First Posted: 2006-11-27
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2015-02
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azelaic acid 15% Gel	Azelaic acid 15% gel	Azelaic acid 15%
Placebo	Non-active base from azelaic acid 15% gel	Non-active base from Azelaic acid 15% gel

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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