Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities (TRUX-LST)
Topical Ruxolitinib as a Treatment of Anti-PD1 Induced Lichenoid Skin Toxicities: a Prospective Single-center Pilot Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- University hospital Zürich, Department Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adult patients eligible for this inclusion in this study have to fulfil all the following criteria:
- Indication: lichenoid skin toxicities / rash which has developed under / after anti-PD-1 therapy.
- Male and Female patients ≥18 years of age
- Patients that are able to speak and read German or English.
- The subject was informed and gave his/her consent to the Institutional Review Boards (IRB)/Independent Ethics Committee (IEC) -approved informed consent
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for the inclusion in this study:
- Patient suffering other skin disease resembling lichenoid skin lesions under anti-PD-1 therapy.
- Acute psychiatric illness or acute crisis.
- Contraindications to ruxolitinib, e.g. known hypersensitivity or allergy
- Topical glucocorticosteroids, topical calcineurin inhibitors and UV light therapy are not allowed during the study or for 1 week before the study beginning. Other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine are not allowed during the study or for 8 weeks before the study beginning.
- 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 study with topical or oral ruxolitinib within the 30 days preceding and during the present study.
- Previous enrolment into the current study.
Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Participants must avoid pregnancy during the study. A blood pregnancy test is required before start of therapy, with regular urine tests throughout. Lactating individuals are ineligible.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Intervention
This study will be performed as one-arm with no comparator.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of patients achieving at least 90% improvement of rash at week 12.
Time Frame: week 12
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The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash. |
week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of patients achieving 75% improvement of rash at week 12.
Time Frame: week 12
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The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash. |
week 12
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Proportion of patients achieving 50% improvement of rash at week 12.
Time Frame: week 12
|
The improvement of rash is defined on the physician global assessment score (PGA) and on the body surface area (BSA). PGA: measures the overall response to treatment as assessed by the physician; scale 0-4 Reduction of PGA (e.g. PGA 4 to PGA0) will be converted into percentage: decrease of PGA of 1 point on a scale from 0 to 4 shows a decrease of 25%, decrease of 4 points shows a decrease of 100%. This value (percentage of PGA decrease) will be combined with the reduction of BSA (percentage) and will result in the improvement of rash. |
week 12
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Percentage change from body surface area at baseline to week 2, 4, 8 and 12
Time Frame: baseline, week 2, 4, 8 and 12
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Calculation of the affected body surface area as a percentage.
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baseline, week 2, 4, 8 and 12
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Proportion of patient reported outcome: Itch Numerical Rating Scale (Itch NRS)
Time Frame: baseline, week 2, 4, 8 and 12
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Itch Numerical Rating Scale (Itch NRS): 2 questions, rating the itch intensity on a scale from 0 to 10 points
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baseline, week 2, 4, 8 and 12
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Proportion of patient reported outcome: Dermatology Life Quality Index (DLQI)
Time Frame: baseline, week 2, 4, 8 and 12
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Dermatology Life Quality Index (DLQI): 10 questions, summing the score of each question resulting in a minimum of 0 and a maximum of 30 points
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baseline, week 2, 4, 8 and 12
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Proportion of patient reported outcome: Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: baseline, week 2, 4, 8 and 12
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Treatment Satisfaction Questionnaire for Medication (TSQM): The TSQM is a questionnaire used to measure patient satisfaction with medication.
The score ranges from 0 to 100 points
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baseline, week 2, 4, 8 and 12
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Proportion of patient reported outcome: Five Well-Being Index (WHO-5)
Time Frame: baseline, week 2, 4, 8 and 12
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Five Well-Being Index (WHO-5): a short self-reported measure of current mental wellbeing.
It consists of five statements, which respondents rate according to a scale between 0 to 5
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baseline, week 2, 4, 8 and 12
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-01779
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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