Effects of Isotretinoin on CYP2D6 Activity

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-26

Study Completion Date

2023-11-27

Brief Summary

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

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Detailed Description

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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

Conditions

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CYP2D6 Polymorphism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adolescents

dextromethorphan pre- and post isotretinoin

Group Type OTHER

Isotretinoin

Intervention Type DRUG

Drug interaction study

dextromethorphan

Intervention Type DRUG

Drug interaction study

Interventions

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Isotretinoin

Drug interaction study

Intervention Type DRUG

dextromethorphan

Drug interaction study

Intervention Type DRUG

Other Intervention Names

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accutane robitussin pediatric

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No