Isotretinoin vs Doxycycline for Drug-Induced Acne
(PNOC039 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether isotretinoin (a form of vitamin A used as a medication) or doxycycline (an antibiotic) is more effective for treating acne-like rashes that appear after certain cancer treatments. These rashes, often on the face, scalp, upper chest, or back, can be uncomfortable and impact daily life. Individuals who develop this type of rash while undergoing cancer treatments targeting the MAPK cell pathway might be suitable candidates. Participants should not have used isotretinoin for at least six months or doxycycline for four weeks before joining. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, if you have taken doxycycline or isotretinoin before, there are specific waiting periods before you can join the study: 4 weeks for doxycycline and 6 months for isotretinoin.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that isotretinoin significantly reduces acne, particularly the red, swollen spots. However, it can cause side effects such as headaches, blurred vision, and dizziness. Some individuals have also reported depression and mood changes, which are rare but serious. Monitoring for these side effects during treatment is important.
Conversely, doxycycline is generally gentler on the body. Research has shown it carries a lower risk of serious side effects. Common but mild side effects include an upset stomach and increased sensitivity to sunlight.
Overall, both treatments have been used for acne and have known side effects. Isotretinoin tends to have more serious potential side effects, while doxycycline is considered safer with fewer severe reactions. Discussing the benefits and risks with a healthcare provider is crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer different approaches to managing drug-induced acne compared to traditional options like topical retinoids or benzoyl peroxide. Isotretinoin, known for treating severe acne, works by reducing oil production and inflammation, potentially offering a more robust solution for drug-induced cases. On the other hand, doxycycline, an antibiotic, addresses acne by tackling bacteria and inflammation, providing a potentially gentler option. These treatments may provide new alternatives for patients who haven't responded well to current standard therapies.
What evidence suggests that this trial's treatments could be effective for drug-induced acne?
This trial will compare the effectiveness of isotretinoin and doxycycline for drug-induced acne. Studies have shown that isotretinoin, which participants in this trial may receive, ranks among the most effective treatments for severe acne, leading to long-term improvement in many patients. One study found that it can reduce acne by up to 84% over 20 weeks. Meanwhile, doxycycline, another treatment option in this trial, is an antibiotic that reduces bacteria and swelling linked to acne. Research shows that doxycycline works well for moderate to severe acne, although full effects may take a few weeks to appear. Both treatments have proven effective for acne, but isotretinoin is often recognized for its strong and lasting results.12678
Who Is on the Research Team?
Sabine Mueller, MD, PhD, MAS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for people who develop an acne-like rash while taking cancer treatments that target the MAPK pathway. Participants must be able to provide blood and stool samples, have their rash photographed, and answer questionnaires.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either isotretinoin or doxycycline for 12 weeks to treat acneiform rash caused by MAPK pathway inhibitors
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Doxycycline
- Isotretinoin
Trial Overview
The study compares two medications—Isotretinoin and Doxycycline—to see which works better at treating rashes caused by certain cancer drugs. Participants are randomly assigned to one of these treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants randomized to the doxycycline arm will receive oral doxycycline daily at a body weight-based dose of 50 mg or 100 mg for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first.
Participants randomized to the isotretinoin arm will be enrolled in the iPLEDGE program prior to treatment initiation. Female participants of childbearing potential will undergo a urine or serum pregnancy test as required for iPLEDGE registration. Participants will receive oral isotretinoin daily at a dose based on body weight, ranging from 10 mg to 40 mg, for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Day One Biopharmaceuticals, Inc.
Industry Sponsor
Citations
Oral Doxycycline in the Management of Acne Vulgaris - PMC
This article reviews data with a new double-scored small 150mg tablet of doxycycline hyclate that has proven functional scoring, exhibits bioavailability ...
Doxycycline for Acne: How Long Do Side Effects Last?
Doxycycline treats acne by killing off bacteria on the skin, so the bacteria can't cause inflammation. Doxycycline also improves acne by ...
A Meta-Analysis of Randomized Controlled Trials
This study indicates that azithromycin pulse therapy is equivalent to doxycycline at 12 weeks in the efficacy of the treatment for moderate to severe acne ...
Effects of Subantimicrobial-Dose Doxycycline in the ...
Twice-daily treatment with SD doxycycline for adults with moderate facial acne for 6 months significantly reduced the number of acne lesions, was well tolerated ...
Comparisons of Efficacy and Safety of Different Doses ...
40 mg/d of doxycycline was significantly more effective than that of placebo 40 mg/d of doxycycline may possess similar efficacy in the ...
Efficacy and safety of oral doxycycline for acne vulgaris ... - PMC
A notable finding was the superior improvement in Global Acne Grading System (GAGS) scores with control interventions compared to doxycycline (MD 1.76; 95% CI [ ...
Effectiveness and Safety of Once-Daily Doxycycline ...
Approximately 12% of patients experienced adverse events with no difference between the two skin type groups. The results of this prospective subgroup analysis ...
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assets.publishing.service.gov.uk
assets.publishing.service.gov.uk/media/686e558581dd8f70f5de3cfc/Serious-or-severe-adverse-effects-experienced-by-people-taking-doxycycline-rapid-review.pdfSerious-or-severe-adverse-effects-experienced-by-people- ...
Overall, there was limited systematic review evidence to suggest that use of doxycycline for short to medium duration of use leads to serious or severe adverse ...
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