Phase 4 N=33 Other

Effects of Isotretinoin on CYP2D6 Activity

CYP2D6 Polymorphism

Bottom Line

View on ClinicalTrials.gov: NCT03076021 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX) — 16.0; 12.5 Ratio

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Isotretinoin (Drug); dextromethorphan (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)	16.0; 12.5	—

Summary

Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.

Eligibility Criteria

Inclusion Criteria

Non-pregnant
≥ 12 years
Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons

Exclusion Criteria

Weight < 80 lbs
Allergy or adverse reaction to dextromethorphan, vitamin A or isotretinoin
Pregnant or planning to become pregnant
Unable to follow isotretinoin risk evaluation and mitigation strategies (REMS) program (also known as iPLEDGE program)
Chronic or persistent cough accompanying asthma, smoking or chronic obstructive pulmonary disease,
Productive cough,
Fever,
Known kidney disease,
Known liver disease,
Diabetes
Obesity, body mass index ≥ 30 kg/m2
Bipolar disease,
Attention deficit disorder,
Social phobia,
Concurrent or use within 14 days of drugs known to interact with dextromethorphan or cytochrome P450 2D6 (CYP2D6) or drugs known to increase the risk of adverse effects from dextromethorphan
Concurrent use of any other product containing dextromethorphan
Consuming foods, beverages or dietary supplements known to interact with dextromethorphan or CYP2D6
Unable to give written informed consent/assent,
Inability to fast for 4 hours prior to study.
Wards of the State

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03076021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.