CYP2D6 PolymorphismPhase 4NCT03076021
Effects of Isotretinoin on CYP2D6 Activity
A Phase 4 study testing Isotretinoin and dextromethorphan in people with CYP2D6 Polymorphism, run by University of Washington at 1 site in United States.
Trial summary
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- CYP2D6 Polymorphism
- What is being tested?
- Isotretinoin and dextromethorphan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2016to 27 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-pregnant
- ≥ 12 years
- Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons
Who cannot join
- 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,
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
Read the 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
- Conditions
- CYP2D6 Polymorphism
- Being tested
- Isotretinoin, dextromethorphan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called accutane
Drug interaction study
dextromethorphanDrug
Also called robitussin pediatric
Drug interaction study
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Other | dextromethorphan pre- and post isotretinoin Receives: Drug: Isotretinoin; Drug: dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)
dextromethorphan (DM)/dextrophan (DX) molar concentration Metabolic Ratio. The metabolic ratio is unit-less as the molar concentrations cancel out.
Measured: 1 week to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start26 Jul 2016
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CYP2D6 PolymorphismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Mary Hebert, University of Washington
- Investigators
- Mary F Hebert, PharmD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076021
- Sponsor's protocol ID
- STUDY00002324
- Other IDs
- R01GM124264
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2017
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, we plan to follow NIGMS/NIH and University of Washington requirements for data sharing.
Publications
Zhao Y, Vary JC Jr, Yadav AS, Czuba LC, Shum S, LaFrance J, Huang W, Isoherranen N, Hebert MF. Effect of isotretinoin on CYP2D6 and CYP3A activity in patients with severe acne. Br J Clin Pharmacol. 2024 Mar;90(3):759-768. doi: 10.1111/bcp.15938. Epub 2023 Nov 21.
PubMed 37864393
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isotretinoin on CYP2D6 Activity
- ClinicalTrials.gov ID
- NCT03076021
- Acronym / sponsor ID
- STUDY00002324
- Conditions
- CYP2D6 Polymorphism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, pre-post drug interaction study evaluating an approved drug (Phase 4) with a Phase 1 study design.
| Arm | Type | Receives |
|---|---|---|
| Adolescents | Other | Drug: Isotretinoin, Drug: dextromethorphandextromethorphan pre- and post isotretinoin |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant
- ≥ 12 years
- Patients with severe acne that are expected to receive isotretinoin for therapeutic reasons
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsotretinoinAlso: accutaneDrug interaction study | Drug | Adolescents |
| dextromethorphanAlso: robitussin pediatricDrug interaction study | Drug | Adolescents |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37864393Zhao Y, Vary JC Jr, Yadav AS, Czuba LC, Shum S, LaFrance J, Huang W, Isoherranen N, Hebert MF. Effect of isotretinoin on CYP2D6 and CYP3A activity in patients with severe acne. Br J Clin Pharmacol. 2024 Mar;90(3):759-768. doi: 10.1111/bcp.15938. Epub 2023 Nov 21.
- Individual participant dataSharing planned: Yes. After completion of the study, we plan to follow NIGMS/NIH and University of Washington requirements for data sharing.
Related trials for CYP2D6 Polymorphism
Not yet recruiting
Evaluation of Solanidine as an Exogenous Biomarker to Phenotype CYP2D6 Activity in Humans
Pharmacokinetic Study in Healthy Volunteers
RecruitingObservational study
Long-term Follow-up of Depressive Disorders in Psychiatric Care
Depression, Psychiatric Diagnosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary F Hebert, PharmD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotretinoin and dextromethorphan in people with CYP2D6 Polymorphism, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX) (time frame: 1 week to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.