A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
Phase 4
Completed
- Conditions
- Papulopustular Rosacea
- Interventions
- Drug: azelaic acid 15% gel
- Registration Number
- NCT00417937
- Lead Sponsor
- LEO Pharma
- Brief 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.
- Detailed Description
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 azelaic acid 15% gel Azelaic acid 15 % gel once daily 2 azelaic acid 15% gel Azelaic acid 15 gel twice daily
- Primary Outcome Measures
Name Time Method Investigator's global assessment scored on a seven point scale Measurements made during the course of treatment
- Secondary Outcome Measures
Name Time Method Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy Parameters measured during the course of treatment
Trial Locations
- Locations (1)
Intendis GmbH
🇩🇪Berlin, Germany