Trial Condition(s):
Papulopustular Rosacea
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
Bayer Identifier:
14428
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Intendis GmbH Berlin, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Investigator's global assessment scored on a seven point scaleTimeframe: Measurements made during the course of treatment
Secondary Outcome
- Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapyTimeframe: Parameters measured during the course of treatment
Additional Information
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