Effects of Isotretinoin on CYP2D6 Activity

January 3, 2025 updated by: Mary Hebert, University of Washington
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Adolescents
dextromethorphan pre- and post isotretinoin
Drug: Isotretinoin
Drug interaction study
Other Names:
  • accutane
Drug: dextromethorphan
Drug interaction study
Other Names:
  • robitussin pediatric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Mary F Hebert, PharmD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2016

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 6, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002324
  • R01GM124264 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completion of the study, we plan to follow NIGMS/NIH and University of Washington requirements for data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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