Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07629167 | Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway | PHASE2 | NOT YET_RECRUITING | 50 | — | — | Aug 30, 2026 | Mar 30, 2030 | Jun 5, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Arm A: Isotretinoin | EXPERIMENTAL | 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. |
| Arm B: Doxycycline | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Isotretinoin | DRUG | Given Orally |
| Doxycycline | DRUG | Given Orally |
| Blood specimen collection | PROCEDURE | Perform blood draw |
| Photographs of Rash | OTHER | Undergo photography |
| Questionnaires | BEHAVIORAL | Participants will be asked to complete questionnaires |
| Stool Specimen collection | PROCEDURE | Perform stool sample collection |
Inclusion Criteria: 1. Participants must have developed either a grade 2, 3, or 4 rash categorized as acneiform while taking tumor-directed therapy that targets the MAPK pathway. * Acneiform rash will be defined according to CTCAE v5.0 as a disorder characterized by an eruption of papules and p...