NCT01474590

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

Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Epiduo/Tactuo	topical to the face, once daily in the evening
OTHER	vehicle gel	topical to the face, once daily in the evening
DRUG	doxycycline 200mg	oral, 2 capsules once daily in the morning with aglass of water and with food
DRUG	Isotretinoin	oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2011-11-18
• Last updated: 2021-02-18
• Results posted: 2017-08-28

Locations

25 sites across 1 country: Canada