A Phase 2 interventional study of Ruxolitinib Topical Cream in Exanthema and Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy, sponsored by University of Zurich. Active, not recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Zurich · Phase 2, Interventional, and Treatment
Skin rash during tumor treatment with immunotherapy (anti-PD1 antibody therapy) is a common side effect. If patients suffer from such a skin reaction, they typically suffer from a rash on the chest, back and extremities. The skin reaction is usually treated with cortisone in cream or tablet form. There is already research in humans on the skin reaction under anti-PD1 antibody therapy. Previous studies in humans have shown that certain inflammatory markers are elevated. It is also know that the study drug can help to reduce these inflammatory markers. However, there is currently not enough data available whether the study drug can actually reduce inflammation in the skin in a rash under anti-PD1 antibody therapy. The investigators are therefore examining in this study whether the study drug is effective and well tolerated in a skin rash under anti-PD1 antibody therapy. The study drug contains the active ingredient ruxolitinib and is applied as a cream. The study drug is approved for other skin diseases (vitiligo and atopic eczema) in the USA and in countries of the European Union (EU). Approval in Switzerland is still pending. Only once the efficacy of the study drug against skin rashes under anti-PD1 antibody therapy has been scientifically investigated and proven can it be approved and used as a therapy in Switzerland. In this study, the participants are not divided into groups. Each study patient receives the test substance.
68 studies on the registry are indexed under Exanthema; 11 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 45 interventional studies indexed under Exanthema.
Browse Exanthema studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
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Adult patients eligible for this inclusion in this study have to fulfil all the following criteria:
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for the inclusion in this study:
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Participants must use effective , either:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study will be performed as one-arm with no comparator.
Drug: Ruxolitinib Topical Cream
Ruxolitinib cream will be applied topically twice daily on up to 20% of the body surface over 12 weeks in patients with lichenoid skin toxicity under anti PD1 treatment.
Also known as: Topical Ruxolitinib (INCB18424)
Proportion of patients achieving at least 90% improvement of rash at week 12.
The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.
Time frame: week 12
Proportion of patients achieving 75% improvement of rash at week 12.
The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.
Time frame: week 12
Proportion of patients achieving 50% improvement of rash at week 12.
The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash.
Time frame: week 12
Percentage change from body surface area at baseline to week 2, 4, 8 and 12
Calculation of the affected body surface area as a percentage.
Time frame: baseline, week 2, 4, 8 and 12
Proportion of patient reported outcome: Itch Numerical Rating Scale (Itch NRS)
Itch Numerical Rating Scale (Itch NRS): 2 questions, rating the itch intensity on a scale from 0 to 10 points
Time frame: baseline, week 2, 4, 8 and 12
Proportion of patient reported outcome: Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index (DLQI): 10 questions, summing the score of each question resulting in a minimum of 0 and a maximum of 30 points
Time frame: baseline, week 2, 4, 8 and 12
Proportion of patient reported outcome: Treatment Satisfaction Questionnaire for Medication (TSQM)
Treatment Satisfaction Questionnaire for Medication (TSQM): The TSQM is a questionnaire used to measure patient satisfaction with medication. The score ranges from 0 to 100 points
Time frame: baseline, week 2, 4, 8 and 12
Proportion of patient reported outcome: Five Well-Being Index (WHO-5)
Five Well-Being Index (WHO-5): a short self-reported measure of current mental wellbeing. It consists of five statements, which respondents rate according to a scale between 0 to 5
Time frame: baseline, week 2, 4, 8 and 12
Ran from Oct 2024 to primary completion in Apr 2026, 18 months.
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