Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
PNOC039
A Phase 2 Study of Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
2 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedStudy Start
First participant enrolled
August 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2029
Study Completion
Last participant's last visit for all outcomes
March 30, 2030
June 5, 2026
May 1, 2026
3 years
June 1, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants who experienced acneiform rash
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.
Up to 12 weeks following treatment
Study Arms (2)
Arm A: Isotretinoin
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participants will be asked to complete questionnaires
Perform stool sample collection
Perform blood draw
Eligibility Criteria
You may qualify if:
- 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 pustules, typically appearing in face, scalp, upper chest and back.
- Grade 2 = Papules and/or pustules covering 10-30% body surface area (BSA), which may or may not be associated with symptoms or of pruritus or tenderness; associated with psychosocial impact; limiting instrumental Activities of Daily Living (ADL); papules and/or pustules covering \> 30% BSA with or without mild symptoms.
- Grade 3 = Papules and/or pustules covering \> 30% BSA with moderate or severe symptoms; limiting self-care ADL; associated with local superinfection with oral antibiotics indicated.
- Grade 4 = Life-threatening consequences; papules and/or pustules covering any % BSA, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated.
- Prior Therapy: Participants may have received either doxycycline or isotretinoin in the past for treatment of their targeted therapy induced rash or acne. However, if they took doxycycline or another tetracycline antibiotic for a rash caused by a targeted therapy or for acne, the last dose must have been at least 4 weeks before study registration. If a participant took isotretinoin for any reason, the last dose must be at least 6 months prior to study registration.
- Age. 12-39 years old.
- Organ Function Requirements.
- a. Adequate Liver Function Defined as:
- 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
- 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.
- Participants must be able and willing to take a gelatin capsule.
- +2 more criteria
You may not qualify if:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxycycline or isotretinoin, or other agents used in study. Participants also must not have a paraben allergy.
- Participants taking any medications listed must be discussed with study chair(s).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, other than skin infection in setting of rash.
- Women of childbearing potential must not be pregnant or breast-feeding.
- Participants who report active suicidal ideation due to isotretinoin's black box warning.
- Participants who refuse to be photographed for the centralized dermatology review.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabine Mueller, MD, PhD, MAS
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 5, 2026
Study Start (Estimated)
August 30, 2026
Primary Completion (Estimated)
August 30, 2029
Study Completion (Estimated)
March 30, 2030
Last Updated
June 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
De-identified datasets may be shared with research collaborators during the course of the study.