Isotretinoin vs. Doxycycline for Acneiform Rash

This study is looking at two different medicines, isotretinoin and doxycycline, to see which one works better at treating a specific skin rash called an "acneiform rash." This rash can happen when people are taking certain cancer treatments that target the MAPK pathway (a specific way cancer cells grow). You might be able to join if you are between 12 and 39 years old and have developed a moderate to severe acneiform rash from these cancer treatments. The main goal is to see how many people's rashes improve after 12 weeks of treatment with either isotretinoin or doxycycline. The study is currently not recruiting new participants.

Study design
This interventional study plans to enroll 50 participants to compare the effectiveness of isotretinoin and doxycycline. It is not specified if participants will know which drug they are receiving.
What's involved
You would take either isotretinoin or doxycycline orally for up to 12 weeks. You would also have blood drawn, photographs taken of your rash, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured up to 12 weeks after treatment. The study also plans to evaluate the need for retreatment 3 months after stopping the study treatment.

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NCT07629167

Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway

Not Yet Recruiting
PHASE2Ages 12–39InterventionalTreatment
University of California, San Francisco
~50 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:IsotretinoinDoxycyclineBlood specimen collectionPhotographs of RashQuestionnairesStool Specimen collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants who experienced acneiform rash
Measured over Up to 12 weeks following treatment
Acneiform Drug Eruption
Acneiform Eruptions
1 sites across 1 states
California1
  • Sabine Mueller, MD, PhD, MAS · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

Acneiform rash will be defined according to CTCAE v5.0 as a disorder characterized by an eruption of papules and pustules, typically appearing in face, scalp, upper chest and back.
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN
alanine aminotransferase (ALT) ≤ 3 x ULN
aspartate aminotransferase (AST) ≤ 3 x ULN.
Serum triglycerides \< 500 mg/dL or \< 5.7 mmol/L 5. Due to the harmful effects of isotretinoin and doxycycline on the developing human fetus women of child-bearing potential and men must agree to use adequate contraception (as recommended by the iPLEDGE system if residing in the United States for those who will take isotretinoin) prior to study entry, for the duration of study participation, and one (1) month after completion of isotretinoin and doxycycline administration. If a participant requires contraception, they will require two forms of contraception as outlined by the iPLEDGE system. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The proper steps in the iPLEDGE system must also be taken. 6. Participants must be able and willing to take a gelatin capsule. 7. Participants must be able to swallow pills. 8. A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
  • Proportion of Participants who experienced acneiform rashUp to 12 weeks following treatment

    The proportion of participants who experience a Grade \< 2 acneiform rash at week 12 while receiving non-investigational treatment for cancer that targets the mitogen activated protein kinase (MAPK) pathway as classified by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and 95% confidence interval will be reported.