A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: December 5, 2006
Last updated: March 18, 2015
Last verified: March 2015
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

Condition Intervention Phase
Seborrheic Dermatitis on the Face
Drug: Azelaic Acid 15% Gel
Drug: Inactive 15% gel base
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 Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment. [ Time Frame: Measurement of parameters during the course of treatment (six weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms [ Time Frame: Measurement of parameters during the course of treatment (six weeks) ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
azelaic acid 15%
Drug: Azelaic Acid 15% Gel
15% gel, topically applied daily for six weeks
Placebo Comparator: 2
Inactive 15% gel base
Drug: Inactive 15% gel base
placebo, topically applied daily for six weeks

Detailed Description:
To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Stable or exacerbating seborrheic dermatitis in the facial area

Exclusion Criteria:

  • Psoriasis
  • Atopic dermatitis
  • Facial acne and rosacea
  • Dermatophytic skin infections
  • Parkinson's disease
  • Known immunosuppression; HIV infection
  • Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
  • Continuous asthma inhalation treatment requiring > 800 mg corticosteroids
  • Any severe disease likely to interfere with the conduct or the planned termination of the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00408330

Blankenfelde-Mahlow, Germany, 15831
Buchholz, Germany, 21244
Hamburg, Germany, 20354
Hamburg, Germany, 22049
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00408330     History of Changes
Other Study ID Numbers: 1401201  2006-002060-26 
Study First Received: December 5, 2006
Last Updated: March 18, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dermatitis, Seborrheic
Sebaceous Gland Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Azelaic acid
Antineoplastic Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016