Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Adult patients eligible for this inclusion in this study have to fulfil all the following criteria: * Indication: lichenoid skin toxicities / rash which has developed under / after anti-PD-1 therapy. * Male and Female patients ≥18 years of age * Patients that are able to speak and read German or English. * The subject was informed and gave his/her consent to the Institutional Review Boards (IRB)/Independent Ethics Committee (IEC) -approved informed consent Exclusion Criteria: Patients fulfilling any of the following criteria are not eligible for the inclusion in this study: * Patient suffering other skin disease resembling lichenoid skin lesions under anti-PD-1 therapy. * Acute psychiatric illness or acute crisis. * Contraindications to ruxolitinib, e.g. known hypersensitivity or allergy * Topical glucocorticosteroids, topical calcineurin inhibitors and UV light therapy are not allowed during the study or for 1 week before the study beginning. Other JAK inhibitors o