Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK … (NCT07629167) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
United States50 participantsStarted 2026-08-30
Plain-language 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.
Who can participate
Age range
12 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants who experienced acneiform rash
. 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.
Exclusion criteria
. 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.