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Isotretinoin + Dextromethorphan for CYP2D6 Polymorphism
Study Summary
This trial will investigate whether the acne medication isotretinoin decreases the activity of the CYP2D6 enzyme in adolescent patients.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are not allowed to eat certain foods, drinks, or take specific supplements that can affect how the study drug works in your body.You have a cough that produces phlegm or mucus.You have severe acne and are planning to take isotretinoin as part of your treatment.You have been taking medications that can interfere with the study drug or increase the risk of side effects within the last 14 days.You are allergic to dextromethorphan, vitamin A, or isotretinoin, or have had a bad reaction to them in the past.You have been diagnosed with attention deficit disorder.You are using any other medication that contains dextromethorphan.You have a long-lasting cough that is related to asthma, smoking, or COPD (a lung disease).You have bipolar disorder.You have a fear of social situations.
- Group 1: Adolescents
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has this particular therapeutic intervention been authorized by the FDA?
"The risk profile of this approved treatment is rated at a 3, as it has been through the fourth and final phase of clinical trials."
How many volunteers have taken part in this clinical experiment?
"Unfortunately, this trail is not presently recruiting. The original post was on July 26th 2016 and the last update was November 1st 2022. However, there are 3 clinical trials that are currently seeking patients with cyp2d6 polymorphism and 27 studies related to the treatment of interest actively accepting enrollees."
What clinical applications is this therapy most often used to address?
"Neuroblastoma (nb) can be treated with this medication, as well as a range of other afflictions such rhinorrhoea, antisepsis, and upper respiratory symptoms."
What other research has been conducted to ascertain the efficacy of this treatment?
"As it stands, there are currently 27 clinical trials that encompass this treatment across the globe. Of those, 8 have advanced to Phase 3 with Sioux Falls, South dakota leading the way in terms of trial numbers. That being said, 765 sites are running studies for this medication's efficacy and safety."
Are there still openings for participants in this experiment?
"At present, this study is not actively recruiting. It was initially shared in July of 2016 and the latest update occurred on November 1st 2022. There are three trials that involve cyp2d6 polymorphism currently open to participants and 27 studies for related treatments searching for new patients."
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