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

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

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.

Study Overview

• Status: Completed
• Conditions: Perioral Dermatitis
• Intervention / Treatment: Drug: Azelaic acid 15% gel; Drug: Non-active base from azelaic acid 15% gel

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10827
  • Dülmen, Germany, 48249
  • Essen, Germany, 45122
  • Recklinghausen, Germany, 45661

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: November 23, 2006
• First Submitted That Met QC Criteria: November 23, 2006
• First Posted (Estimated): November 27, 2006

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Facial Dermatoses; Dermatitis; Dermatitis, Perioral; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 1400418; 2006-002471-40 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No