At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 925 enrolled
Drug / intervention
CIP-Isotretinoin +1 moredrug
Likely dose
CIP-Isotretinoin 0.5 mg/kgfrom 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.
A Double-Blind, Randomized, Phase III, Parallel Group Study Evaluating the Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
In Brief
A Phase 3 clinical trial evaluating CIP-Isotretinoin and Isotretinoin for Severe Nodular Acne. Completed, enrolled 925 participants across 49 sites in 2 countries.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Nodular Acne
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedSep 11, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.8 years ago
Interventions
CIP-Isotretinoindrug
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.
Isotretinoindrug
0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.