A Phase 2 Study of Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
University of California, San Francisco
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.
Description
PRIMARY OBJECTIVES: 1\. To compare the efficacy of the isotretinoin and doxycycline after 12 weeks of therapy in patients who develop an acneiform rash caused by a MAPK pathway-inhibitor, measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. EXPLORATORY OBJECTIVES: 1. To assess feasibility of a centralized dermatology review to confirm rash grading and response to treatment. 2. The participants' Multinational Association of Supportive Care in Cancer (MASCC) Epidermal Growth Factor Receptor Inhibitors (EGFRI) Skin Toxicity Tool (MESST) scores will be compared to CT…
Eligibility
- Age range
- 12–39 years
- Sex
- All
- Healthy volunteers
- No
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 pustules, typically appearing in face, scalp, upper chest and back. 1. 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…
Interventions
- DrugIsotretinoin
Given Orally
- DrugDoxycycline
Given Orally
- ProcedureBlood specimen collection
Perform blood draw
- OtherPhotographs of Rash
Undergo photography
- BehavioralQuestionnaires
Participants will be asked to complete questionnaires
- ProcedureStool Specimen collection
Perform stool sample collection
Location
- University of California, San FranciscoSan Francisco, California