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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00403949
First Posted: November 27, 2006
Last Update Posted: February 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403949


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00403949     History of Changes
Other Study ID Numbers: 1400418
2006-002471-40 ( EudraCT Number )
First Submitted: November 23, 2006
First Posted: November 27, 2006
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Azelaic acid
Antineoplastic Agents
Dermatologic Agents