drugset / Trial / NCT01014689

Comparison of Epiduo Associated With Lymecycline Versus Epiduo Vehicle Associated With Lymecycline in Acne Vulgaris

NCT01014689

Phase 3 Completed 378 enrolled Galderma R&D
RandomizedParallel-groupDouble-blindTreatment

Summary

Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face. The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Timeline

Start
2009-08
Primary completion
2010-04
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adapalene Other / unclassified 0.1 % Topical
Comparator Benzoyl Peroxide Other / unclassified 2.5 % Topical
Comparator Lymecycline Unknown 300 mg

Indications