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Completed

NCT Number: NCT03076021

Effects of Isotretinoin on CYP2D6 Activity

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

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Key information

Conditions

CYP2D6 Polymorphism

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

In this aim, we will conduct a drug-drug interaction study evaluating the effects of 13-cis-retinoic acid on non-induced CYP2D6 activity in adolescent patients. Secondary analysis will evaluate the relationship between retinoid concentrations and CYP2D6 activity in these special populations

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

isotretinoin

Drug

Drug interaction study

Other names: accutane

dextromethorphan

Drug

Drug interaction study

Other names: robitussin pediatric

Primary outcomes

  1. CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)

    Time frame: 1 week to 6 months

    dextromethorphan (DM)/dextrophan (DX) molar concentration Metabolic Ratio. The metabolic ratio is unit-less as the molar concentrations cancel out.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2017
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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