At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 266 enrolled
Drug / intervention
Epiduo/Tactuo +3 moredrug
Likely dose
doxycycline 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Epiduo/Tactuo, vehicle gel, and 2 other interventions for Acne. Completed, enrolled 266 participants across 25 sites.
Detailed Summary
Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne
CountriesCanada
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionJul 2013
Study CompletionAug 2013
TodayJul 2026
First PostedNov 18, 2011
Enrollment StartNov 1, 2011
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 14.6 years ago
Interventions
Epiduo/Tactuodrug
topical to the face, once daily in the evening
vehicle gelother
topical to the face, once daily in the evening
doxycycline 200mgdrug
oral, 2 capsules once daily in the morning with aglass of water and with food
Isotretinoindrug
oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.