This phase II trial compares the use of isotretinoin to doxycycline for the treatment of acneiform rash in patients receiving medication that targets the MAPK pathway. Tumor-directed therapies that target the MAPK pathway commonly trigger a variety of skin related (cutaneous) side effects. Cutaneous side effects classified as acneiform rash are frequent and can be difficult to manage. Not only are these cutaneous side effects common, but they can cause significant discomfort and/or changes to the patient’s physical appearance, affect the patient’s quality of life, and sometimes require dose reductions or stopping of the patient’s tumor-directed therapy. Isotretinoin is a medicine that helps reduce skin inflammation and oil production, which can improve acne-like rashes. Doxycycline is a medicine that helps decrease bacteria and inflammation in the skin, which can help reduce acne-like rashes. It is not yet known if isotretinoin or doxycycline is most effective for the treatment of acneiform rash in patients receiving medication that targets the MAPK pathway.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07629167.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Approved
Contact: Sabine Mueller
Phone: 415-476-3831
PRIMARY OBJECTIVE:
I. 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 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
EXPLORATORY OBJECTIVES:
I. To assess feasibility of a centralized dermatology review to confirm rash grading and response to treatment.
II. The participants’ Multinational Association of Supportive Care in Cancer EGFRI Skin Toxicity Tool (MESST) scores will be compared to their CTCAE scores.
III. To measure time to rash response by comparing CTCAE rash scores.
IV. To measure the change in quality-of-life scores from baseline to after 12 weeks of doxycycline or isotretinoin therapy using the Children’s Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI).
V. To record adverse events caused by doxycycline or isotretinoin and any cutaneous adverse events thought to be caused by the targeted agent per CTCAE version 5.0.
VI. To characterize cutaneous toxicities across participants with different skin colors and tones.
VII. To measure the frequency of dose alterations in the MAPK inhibitor and then compare between the two study arms.
VIII. To evaluate the number of participants who require retreatment of their rash 3 months after stopping study treatment.
IX. To describe the microbiome profile in participants receiving doxycycline and isotretinoin.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive isotretinoin orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study.
ARM B: Patients receive doxycycline PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection during screening.
After completion of study treatment, patients are followed up at 30 days and 3 and 6 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorSabine Mueller
