Study on the application of Ruxolitinib cream in patients with rash under anti-PD1 cancer therapy
Descrizione riassuntiva dello studio
Rash under tumor treatment with immunotherapy (anti-PD1 antibody therapy) is a common side effect. When such a skin reaction occurs, patients typically suffer from a rash on the chest, back, and extremities. The skin reaction is usually treated with cortisone as a cream or tablet. There is already research on humans regarding the skin reaction under anti-PD1 antibody therapy. Previous studies in humans have shown that certain inflammatory markers are elevated. We also know that the study medication may help reduce these inflammatory markers. However, we do not yet have data on whether the study medication can actually reduce inflammation in the skin in cases of rash under anti-PD1 antibody therapy. Therefore, we are investigating in this study whether the study medication is effective and well tolerated in cases of rash under anti-PD1 antibody therapy. The study medication contains the active ingredient Ruxolitinib and is applied as a cream. The study medication is approved for other skin diseases (vitiligo and atopic eczema) in the USA and in EU countries, respectively only in the USA. Approval in Switzerland is still pending. Only when the efficacy of the study medication against rashes under anti-PD1 antibody therapy is scientifically investigated and proven can it be approved in Switzerland and used as a treatment. In our study, participants will not be divided into groups. Each study patient will receive the investigational substance.
(BASEC)
Intervento studiato
Topical application of 1.5% INCB18424 (Ruxolitinib cream) twice daily on lesional skin over 12 weeks
(BASEC)
Malattie studiate
Lichenoid rashes under anti-PD1 tumor therapy
(BASEC)
- Indication: lichenoid rash that developed under / after anti-PD-1 therapy - Male and female patients aged ≥18 years - The participant has been informed and has given their consent to the IRB/IEC approved informed consent form (BASEC)
Criteri di esclusione
- Patient with other skin diseases resembling lichenoid rashes under anti-PD-1 therapy - Pregnant or breastfeeding women - Topical glucocorticoids, topical calcineurin inhibitors, UV light therapy, therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine are not allowed during the study or in the 8 weeks prior to the start of the study (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Universitätsspital Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Barbara Meier-Schiesser
+41-43-2539439
barbara.meier-schiesser@clutterusz.chUniversitätsspital Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
09.02.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Topical Ruxolitinib as a treatment of anti-PD1 induced lichenoid skin toxicities: a prospective single-center pilot study (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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