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Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

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Contents

clinicaltrials.gov/study/NCT06399029
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT063990290
Trial Recruitment Size
200
Trial Sponsor
University of Zurich
University of Zurich
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2025
0
Study Completion Date
2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 20
Official Name
Topical Ruxolitinib as a Treatment of Anti-PD1 Induced Lichenoid Skin Toxicities: a Prospective Single-center Pilot Study0
Last Updated
May 3, 2024
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Ruxolitinib Topical Cream0
Study 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.

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