ASSESSMENT OF THE EFFICACY AND SAFETY OF THREE CONCENTRATIONS: 1%, 0.3%, 0.1% OF CD5024 CREAM ONCE DAILY AND CD5024 1% CREAM TWICE DAILY, VERSUS ITS VEHICLE AND VERSUS METRONIDAZOLE 0.75% CREAM (ROZEX®), IN PATIENTS WITH PAPULO-PUSTULAR ROSACEA OVER 12 WEEKS
- Conditions
- Patients with papulo-pustular rosaceaMedDRA version: 9.0Level: LLTClassification code 10039218
- Registration Number
- EUCTR2006-001999-20-HU
- Lead Sponsor
- Galderma Research & Development SNC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
Male or female subjects with papulo-pustular rosacea with at least 15 inflammatory facial lesions, at least 18 years old, meeting specific inclusion and exclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, and secondary rosacea form, isolated erythrosis, isolated rhinophyma, or isolated pustulosis of the chin),
2. The subject has other dermatological disorders such as peri-oral dermatitis, other forms of demodicidosis, facial keratosis pilaris, actual or history of seborrheic dermatitis, which may confound the study assessments,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method