Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

Conditions

• Exanthema
• Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib Topical Cream — DRUG
  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.

Study Details

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.

Key Dates

Start date

Oct 10, 2024

Status verified

Apr 2026

Primary completion

Apr 22, 2026

Completion

May 31, 2026

Study Design

Enrollment

22 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Intervention
  This study will be performed as one-arm with no comparator.

Primary Outcome Measure

Proportion of patients achieving at least 90% improvement of rash at week 12. [ Time Frame: week 12 ]