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Sponsored by: |
Intendis GmbH |
---|---|
Information provided by: | Intendis GmbH |
ClinicalTrials.gov Identifier: | NCT00408330 |
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 |
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 |
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
|
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:
Exclusion Criteria:
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 |
Dermatitis, Seborrheic Azelaic acid Skin Diseases Facies |
Skin Diseases, Eczematous Sebaceous Gland Diseases Skin Diseases, Papulosquamous Dermatitis |
Dermatitis, Seborrheic Azelaic acid Skin Diseases Antineoplastic Agents Therapeutic Uses Skin Diseases, Eczematous |
Sebaceous Gland Diseases Dermatologic Agents Skin Diseases, Papulosquamous Pharmacologic Actions Dermatitis |