At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 201 enrolled
Drug / intervention
Isotretinoindrug
Likely dose
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.
An Open-label Study Evaluating the Long-term Efficacy, Quality of Life, and Safety of ABSORICA® (Isotretinoin) Capsules Administered Without Food in Patients With Severe Recalcitrant Nodular Acne
In Brief
A Phase 4 clinical trial evaluating Isotretinoin for Acne. Completed, enrolled 201 participants across 1 site.
Detailed Summary
This is an uncontrolled, open-label study being conducted in approximately 200 healthy males, non-pregnant, non-nursing females, age 12 to 45 years, with severe recalcitrant nodular acne. ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day will be administered for 4 weeks followed by 1.0 mg/kg/day for 16 weeks. Female subjects consenting to use two forms of birth control or abstinence are included.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedMay 2015
Primary CompletionApr 2018
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartJan 21, 2015
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.1 years ago
Interventions
Isotretinoindrug
ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks