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 at Screening visit, 2. The subject has severe papulopustular rosacea with an Investigator Global Assessment (IGA) score = 4 (See section 7.1.1) at Baseline visit, 3. The subject has at least 25 inflammatory facial rosacea lesions (papules and pustules) at Baseline visit, 4. The subject has a body weight between 45 and 100 Kg at Screening visit, 5. The subject has a Body Mass Index (BMI) between 18 and 30Kg/m2 at Screening visit, 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 other dermatoses that may be confounded with papulopustular rosacea, such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis at Screening visit, 2. The subject has a known coagulation disorder or is treated with anticoagulants at Screening or Baseline visits 3. The subject has any clinically significant blood abnormality (haematology or biochemistry) which might interfere with the pharmacokinetic assessments or would put the subject at risk at Baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to investigate the pharmacokinetic profile of CD 5024 1% cream applied once daily for 4 weeks in subjects with severe papulopustular rosacea in maximal use conditions.;Secondary Objective: ;Primary end point(s): | — |
Countries
France, Germany, Hungary
Outcome results
None listed