Subject who was successfully treated for his/her papulo-pustular rosacea in the initial study (Galderma Study: Eudract N°: 2006-001999-20/RD.03.SPR.40027) MedDRA version: 8.1 Level: LLT Classification code 10039218 Term: Rosacea
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Galderma Research and Development SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subject, at least 18 years old, whose papulo-pustular rosacea was successfully treated (score 0 or 1, grade “clear” or “almost clear” on a 5-point scale, called Investigator Global Assessment Scale 2) in the initial study (RD.03.SPR.40027) and who will be willing to participate in this study, 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 is planning to be enrolled in an investigational drug or device study during the study 2. The subject is willing to take one of the following treatment which might have an impact in the evaluation of the relapses (eg. subject requesting a maintenance therapy) a. Topically applied to the face: astringents or abrasives, antibiotics i.e. metronidazole or macrolides, anti-rosacea drugs (e.g. azelaic acid…), immunomodulators, corticosteroids, retinoids, antiparasitics; b. systemic: antibiotics (i.e. cyclines, macrolides, metronidazole), corticosteroids, ivermectin and others antiparasitics, retinoids, corticosteroid with prolonged activity ; c. Others: Laser or IPL (Intense pulsed light) treatment, telangiectases electrocoagulation, dermabrasion/peeling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this exploratory 6-month treatment-free follow-up study is to evaluate relapses in patients who were successfully treated in an initial Dose-range study (RD.03.SPR.40027) with CD5024 cream or its vehicle or metronidazole 0.75% cream (Rozex®).;Secondary Objective: ;Primary end point(s): • Time to relapse according to the three definition of the relapse • Relapse rate according to the three definition of the relapse • Change from baseline in erythema score. • Change from baseline in telangiectasis score. • Change from baseline in Investigator Global Assessment score 1 (IGA 1). | — |
Countries
Czech Republic, Germany, Hungary
Outcome results
None listed