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

Sponsored by:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00408330

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: azelaic acid 15% gel Drug: Inactive 15% gel base	Phase II

Drug Information available for: Azelaic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Intendis GmbH:

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

Arms	Assigned Interventions
1: Active Comparator azelaic acid 15%	Drug: Azelaic Acid 15% Gel 15% gel, topically applied daily for six weeks Drug: azelaic acid 15% gel 15% gel, topically applied daily for six weeks
2: Placebo Comparator 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

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

Locations

Germany
Intendis GmbH
Berlin, Germany

Sponsors and Collaborators

Intendis GmbH

Investigators

Study Director:

Intendis GmbH

More Information

Additional Information:

(Click here and search for drug information provided by the FDA) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Intendis GmbH ( Klaus Graupe, Senior Medical Advisor )
Study ID Numbers:	1401201
Study First Received:	December 5, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00408330 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Dermatitis, Seborrheic
Azelaic acid
Skin Diseases
Facies

Skin Diseases, Eczematous
Sebaceous Gland Diseases
Skin Diseases, Papulosquamous
Dermatitis

Additional relevant MeSH terms:

Dermatitis, Seborrheic
Azelaic acid
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Skin Diseases, Eczematous

Sebaceous Gland Diseases
Dermatologic Agents
Skin Diseases, Papulosquamous
Pharmacologic Actions
Dermatitis

ClinicalTrials.gov processed this record on May 07, 2009