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

Conditions

• Acneiform Drug Eruption
• Acneiform Eruptions

Eligibility Criteria

Sex

ALL

Age

12 Years - 39 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

A phase 2 study testing the efficacy of isotretinoin versus doxycycline in treating participants who develop a acneiform rash caused by standard of care, tumor-directed therapies targeting the mitogenactivated protein kinase (MAPK) pathway.

Key Dates

Start date

Aug 30, 2026

Status verified

May 2026

Primary completion

Aug 30, 2029

Completion

Mar 30, 2030

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Isotretinoin
  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.
• Experimental: Arm B: Doxycycline
  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.

Primary Outcome Measure

Proportion of Participants who experienced acneiform rash [ Time Frame: Up to 12 weeks following treatment ]

Central Contacts

• Jannerfer An
  877-827-3222
  [email protected]

Locations (1)

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