A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
Information source: Intendis GmbH
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Papulopustular Rosacea
Intervention: azelaic acid 15% gel (Drug); azelaic acid 15% gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Intendis GmbH Official(s) and/or principal investigator(s):
Intendis GmbH, Study Director, Affiliation: Intendis GmbH
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Investigator's global assessment scored on a seven point scale
Secondary outcome: Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
Detailed description:
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on
papulopustular rosacea
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or
pustules
Exclusion Criteria:
- Mild or severe rosacea
- Rosacea with marked ocular manifestations
- Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation
of the study course
- Wash out period required for patients treated prior to study with topical retinoids,
oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical
imidazole, laser surgery for telangiectasia
- History of hypersensitivity to propylene glycol
Locations and Contacts
Intendis GmbH, Berlin, Germany
Additional Information
(Click here and search for drug information provided by the FDA)
Starting date: January 2007
Ending date: June 2007
Last updated: December 3, 2007
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