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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: November 23, 2006
Last updated: February 15, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Perioral Dermatitis
Drug: Azelaic acid 15% gel
Drug: Non-active base from azelaic acid 15% gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Intensity of single signs and symptoms [ Time Frame: 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 [ Time Frame: Safety parameters recorded at scheduled visits during the course of the study ]

Enrollment: 48
Study Start Date: November 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00403949

Berlin, Germany, 10827
Dülmen, Germany, 48249
Essen, Germany, 45122
Recklinghausen, Germany, 45661
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00403949     History of Changes
Other Study ID Numbers: 1400418
2006-002471-40 ( EudraCT Number )
Study First Received: November 23, 2006
Last Updated: February 15, 2015

Additional relevant MeSH terms:
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Azelaic acid
Antineoplastic Agents
Dermatologic Agents processed this record on May 25, 2017