Patients with papulo-pustular rosacea MedDRA version: 9.0 Level: LLT Classification code 10039218
Conditions
Interventions
Product Name: CD5024
Product Code: CD5024
Pharmaceutical Form: Cream
INN or Proposed INN: IVERMECTIN
CAS Number: 70288-86-7
Current Sponsor code: CD5024
Other descriptive name: ANTI PARASITIC
Concentr
Sponsors
Galderma Research & Development SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to select the dose and regimen according to dose-response relationship of CD5024;Secondary Objective: ;Primary end point(s): Primary efficacy endpoint: The primary efficacy analysis on percent changes in inflammatory lesions will be the pairwise comparison of each CD5024 dosage group versus vehicle, using the Cochran-Mantel-Haenszel test (CMH), with analysis center as strata, row mean score difference statistic and ridit transformation (FREQ procedure from SAS). To minimize multiplicity issue, the interpretation of each test will be stepwise, i.e. a dose will be declared significantly more effective than vehicle conditionally on the significant difference versus vehicle of all the higher doses. The CMH test will be used to derive non parametric 95% confidence intervals for the median difference between each dosage and vehicle, at week 12 (ITT-LOCF) and at week 12 (PP-Observed Cases). The secondary analysis will compare each CD5024 dosage versus metronidazole and will use the same test and principles as described above for the comparison versus vehicle. | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed