At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 33 enrolled
Drug / intervention
Isotretinoin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age ≥12 years
- ✓Non-pregnant
- ✓Severe acne expected to receive isotretinoin for therapeutic reasons
Key exclusion· 16
- ✕Weight <80 lbs
- ✕Allergy or adverse reaction to dextromethorphan, vitamin A, or isotretinoin
- ✕Pregnant or planning pregnancy
- ✕Unable to comply with isotretinoin iPLEDGE REMS program
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Isotretinoin on CYP2D6 Activity
In Brief
A Phase 4 clinical trial evaluating Isotretinoin and dextromethorphan for CYP2D6 Polymorphism. Completed, enrolled 33 participants across 1 site.
Detailed Summary
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCYP2D6 Polymorphism
CountriesUnited States
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJul 2016
First PostedMar 2017
Primary CompletionNov 2023
TodayJul 2026
First PostedMar 9, 2017
Enrollment StartJul 26, 2016
Primary CompletionNov 27, 2023
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 9.3 years ago
Interventions
Isotretinoindrug
Drug interaction study
dextromethorphandrug
Drug interaction study