Effects of Isotretinoin on CYP2D6 Activity (NCT03076021) | Clinical Trial Compass
CompletedPhase 4
Effects of Isotretinoin on CYP2D6 Activity
United States33 participantsStarted 2016-07-26
Plain-language summary
Specific Aim: To investigate if isotretinoin (13-cis-retinoic acid) administration decreases CYP2D6 activity in adolescent patients.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
CYP2D6 Activity as Measured by the Molar Concentration Ratio of Dextromethorphan (DM)/Dextrophan (DX)