Effects of Isotretinoin on CYP2D6 Activity

• Status: Active, not recruiting
• Trial end date: 2026-07-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of General Medical Sciences (NIGMS)
• Treatments: Dextromethorphan; Isotretinoin

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 COPD,

• Productive cough,

• Fever,

• Known kidney disease,

• Known liver disease,

• Diabetes

• Obesity, BMI ≥ 30 kg/m2

• Bipolar disease,

• Attention deficit disorder,

• Social phobia,

• Concurrent or use within 14 days of drugs known to interact with DM or CYP2D6 or drugs known to increase the risk of adverse effects from DM

• Concurrent use of any other product containing dextromethorphan

• Consuming foods, beverages or dietary supplements known to interact with DM or CYP2D6

• Unable to give written informed consent/assent,

• Inability to fast for 4 hours prior to study.

• Wards of the State