PAPULOPUSTULAR ROSACEA MedDRA version: 9.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Sponsors
GALDERMA R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is a male or female who is at least 18 years old, 2. The subject has moderate or severe (IGA=3 or 4) papulopustular rosacea 3. The subject has at least 15 and no more than 70 inflammatory facial rosacea lesions (papules and pustules), 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
Exclusion criteria
Exclusion criteria: 1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, and secondary rosacea form, isolated rhinophyma, isolated pustulosis of the chin or ocular rosacea requiring a treatment), or other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, 2. The subject has ocular rosacea requiring either a systemic treatment or an interfering treatment, 3. The subject has rosacea with more than two nodules,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this Phase 3 study is to generate comparative efficacy and safety data of CD5024 1% cream once daily versus Metronidazole 0.75% cream twice daily in subjects with papulopustular rosacea, after up to 16-week topical treatment. The study is powered to detect superiority of CD5024 1% cream over Metronidazole 0.75% cream in term of percent reduction of inflammatory lesions.;Secondary Objective: ;Primary end point(s): Percent change in inflammatory lesions from baseline to Week 16 (ITT-LOCF) Time to onset of efficacy will be determined, once percent change in inflammatory lesion count are statistically significant. | — |
Countries
France
Outcome results
None listed