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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00408330
First received: December 5, 2006
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408330

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

Additional Information:
No publications provided

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 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dermatitis
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 October 23, 2014