A Study to Evaluate JAK Inhibitor Cream in EGFR-inhibitor-induced Skin Rash (NCT05120362) | Clinical Trial Compass
UnknownNot Applicable
A Study to Evaluate JAK Inhibitor Cream in EGFR-inhibitor-induced Skin Rash
China12 participantsStarted 2021-11-03
Plain-language summary
Epidermal growth factor receptor inhibitors (EGFRIs) are widely used targeted agents that have been approved for the treatment of various tumor types. In some clinical studies with EGFRIs, the incidence of dermatology AE, the skin rash, is reportedly as high as 95%, which profoundly impact the patients' quality of life. However no treament for onset skin rash has been approved to be effective by any clinical trial yet. Janus kinase (JAK) inhibitor, has been approved for or studied in a variety of skin conditions such as alopecia areata, atopic dermatitis, and psoriasis. Thus the investigators intend to evaluate the efficacy and safety of JAK inhibitor cream for the treatment of EGFRIs-induced skin rash in cancer patients.
Who can participate
Age range
18 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:
* 18 years of age or older.
* Pathologically confirmed cancer receiving EGFRI-based therapy (monotherapy or as part of a combination therapy regimen).
* Skin rash causally related to EGFRI therapy of grade 1 or higher (according to MESTT criteria).
* ECOG performance score \< 2.
* Able to use topical medications and complete questionnaires reliably with or without assistance.
* Life expectancy of greater than 6 months.
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Use of any other topical medications in the treatment areas (face) within 7 days prior to randomization or duing the study.
* Use of Tetracycline (e.g. minocycline, doxycycline) within 14 days prior to randomization or duing the study.
* Use of other cancer medications known to result in skin rash in the face or upper chest/upper back area within 4 weeks prior to randomization or duing the study.
* Known hypersentitivity to JAK inhibitors.
* With other skin disorders that may affect efficacy evaluation, including but not limited to: eczema, psoriasis, etc.
* Uncontrolled intercurrent illness.
* Significantly abnormal lab test.
* Pregnant or nursing women.
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.