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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00403949
First received: November 23, 2006
Last updated: February 23, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intensity of single signs and symptoms [ Time Frame: Measured at scheduled visits during the course of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

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: 2
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00403949     History of Changes
Other Study ID Numbers: 1400418, 2006-002471-40
Study First Received: November 23, 2006
Last Updated: February 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014