drugset / Trial / NCT01493947

CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

NCT01493947

Phase 3 Completed 962 enrolled Galderma R&D
RandomizedParallel-groupSingle-blindTreatment

Summary

Study objectives: * To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. * And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Timeline

Start
2012-04
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivermectin Small molecule 1 % Topical
Comparator Metronidazole Small molecule 0.75 % Topical

Indications