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Sponsored by: |
Intendis GmbH |
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Information provided by: | Intendis GmbH |
ClinicalTrials.gov Identifier: | NCT00417937 |
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.
Condition | Intervention | Phase |
---|---|---|
Papulopustular Rosacea |
Drug: azelaic acid 15% gel |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea |
Enrollment: | 98 |
Study Start Date: | January 2007 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Azelaic acid 15 % gel once daily
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Drug: azelaic acid 15% gel
15% gel, topically applied once daily for six weeks
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2: Active Comparator
Azelaic acid 15 gel twice daily
|
Drug: azelaic acid 15% gel
15% gel, topically applied twice daily for six weeks
|
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea
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: | 1401460 |
Study First Received: | January 2, 2007 |
Last Updated: | December 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00417937 |
Health Authority: | United States: Food and Drug Administration |
Rosacea Azelaic acid Skin Diseases |
Antineoplastic Agents Therapeutic Uses Dermatologic Agents Pharmacologic Actions |