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Completed

NCT Number: NCT00403949

A Study of Azelaic Acid (AzA) 15% in 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.

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Key information

Conditions

Perioral Dermatitis Dermatitis Dermatitis, Perioral Facial Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azelaic acid 15% Gel

Drug

gel, applied once daily, for 6 weeks

Non-active base from azelaic acid 15% gel

Drug

gel, apply once daily for six weeks

Primary outcomes

  1. The sum score derived from the most important signs and symptoms of perioral dermatitis

    Time frame: Measurements and observations during the course of the study

Secondary outcomes

  1. Intensity of single signs and symptoms

    Time frame: Measured at scheduled visits during the course of the study

  2. Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator

    Time frame: Safety parameters recorded at scheduled visits during the course of the study

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 27, 2006
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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