Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Phase 3 Completed 266 enrolled Galderma R&D

RandomizedParallel-groupSingle-blindTreatment

Summary

Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.

Timeline

Start: 2011-11
Primary completion: 2013-07
Completion: 2013-08

Publications

Tan J, Humphrey S, Vender R, Barankin B, Gooderham M, Kerrouche N, Audibert F, Lynde C; POWER study group. A treatment for severe nodular acne: a randomized investigator-blinded, controlled, noninferiority trial comparing fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin. Br J Dermatol. 2014 Dec;171(6):1508-16. doi: 10.1111/bjd.13191. Epub 2014 Oct 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adapalene	Other / unclassified	0.1 %	Topical
Subject	Benzoyl Peroxide	Other / unclassified	2.5 %	Topical
Subject	Doxycycline	Small molecule	200 mg	Oral
Comparator	Isotretinoin	Other / unclassified	1 mg/kg	Oral

Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

Summary

Timeline

Publications

Drugs

Indications