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

Perioral Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403949
• Other study ID #: 1400418
• Secondary ID: 2006-002471-40
• Status: Completed
• Phase: Phase 2
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Perioral Dermatitis

Intervention

Drug:
• Azelaic acid 15% gel
gel, applied once daily, for 6 weeks
• Non-active base from azelaic acid 15% gel
gel, apply once daily for six weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sum score derived from the most important signs and symptoms of perioral dermatitis		Measurements and observations during the course of the study
Secondary	Intensity of single signs and symptoms		Measured at scheduled visits during the course of the study
Secondary	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