Topical Ruxolitinib Evaluation in Immune-related Vitiligo-like Depigmentation | NCT07725432

NCT07725432

Overview

NCT ID: NCT07725432
Lead Sponsor: University of ZurichOTHER
Official Title: Topical Ruxolitinib for the Treatment of Immune-related Vitiligo-like Depigmentation: A Prospective, Multicentre Study of a Topical JAK-inhibitor
Brief Summary: White spot disease is a common side effect on the skin in the context of cancer treatments with immunotherapies. There is no standard therapy yet for white spot caused by cancer therapies. There is already research in humans on the treatment of white spot disease. Previous human studies with ruxolitinib cream have shown that approximately 30% of patients with white spot disease have achieved a 75% improvement (re-pigmentation) of their affected areas after 24 weeks and approximately 50% of patients have achieved a 75% improvement after 52 weeks. It is also know that a 50% improvement was observed in over 50% of patients after 24 weeks and a 90% improvement in over 15% of patients. However, these studies to date have not included patients with white spot disease caused by cancer therapy. Therefore, we do not know how well the cream works in this situation. In this study, the investigators are therefore examining whether the investigational substance ruxolitinib is effective and well tolerated in white spot disease caused by cancer therapy. The test substance has not yet been approved in Switzerland. Only once the efficacy of the investigational substance ruxolitinib has been scientifically investigated and proven can it be approved in Switzerland and used to treat white spot disease caused by cancer therapy.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jul 25, 2024Actual
Primary Completion Date: Jul 7, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adult patients eligible for this inclusion in this study have to fulfil all the following criteria:

Age 18 years

Written informed consent of the patient

Sufficient fluency in German language skills to complete all questionnaires of the study without external assistance

Treatment-related, immune-related vitiligo-like depigmentation of at least 5% body surface area of one region (face or one upper or lower extremity or front or back side of the trunk)

Female participants must use effective contraceptives, either: An ovulation-inhibiting method (e.g., pill, injectable, implant, patch, or vaginal ring) or an intrauterine device (IUD). Contraception should extend one week post-study. If pregnancy occurs during or within one week after the study, participants should notify the overseeing physician immediately.

During participation in the study and up to one week afterwards, male participants may only have sexual intercourse with condoms. Female partners of male participants must use a highly effective contraceptive method during the partner's participation in the study and for up to 1 week afterwards

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for the inclusion in this study:

Acute psychiatric illness (except mild to moderate depression)

Contraindications to ruxolitinib, e.g. known hypersensitivity or allergy

Use of topical glucocorticosteroids, topical calcineurin inhibitors, UV light therapy, therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine are not allowed during the study period (no wash out period required).

Women who are pregnant or breast feeding

Intention to become pregnant during the course of the study

Known or suspected non-compliance, drug or alcohol abuse.

Patients with an active, serious infection, including localized infections.

Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant.

Participation in another trial with topical or oral ruxolitinib within the 30 days preceding and during the present study.

Simultaneously participation in clinical trials with intervention with a drug other than ruxolitinib (except registry studies)

Previous enrolment into the current study.

Enrolment of the investigator, his/her family members, employees and other dependent persons.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 34Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Universitätsspital Zürich

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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