Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399029
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-25
Brief Title:
Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Topical Ruxolitinib as a Treatment of Anti-PD1 Induced Lichenoid Skin Toxicities a Prospective Single-center Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRUX-LST
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None