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ExanthemaPhase 2TRUX-LSTNCT06399029

Topical Ruxolitinib Evaluation in Immune-related Lichenoid Skin-Toxicities

A Phase 2 study testing Ruxolitinib Topical Cream in people with Exanthema and Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy, run by University of Zurich at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ruxolitinib Topical Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSwitzerland
Study dates
10 Oct 2024to May 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 *
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University hospital Zürich, Department Dermatology

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Topical Ruxolitinib as a Treatment of Anti-PD1 Induced Lichenoid Skin Toxicities: a Prospective Single-center Pilot Study

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.

Being tested
Ruxolitinib Topical Cream
Medical subject headings
Exanthema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ruxolitinib Topical CreamDrug

    Also called Topical Ruxolitinib (INCB18424)

    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 groups in NCT06399029
Study groupRoleWhat they receive
Experimental InterventionExperimentalThis study will be performed as one-arm with no comparator.
Receives: Drug: Ruxolitinib Topical Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients achieving at least 90% improvement of rash at 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.

    Measured: week 12

Secondary outcomes (7)

  1. Proportion of patients achieving 75% improvement of rash at 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.

    Measured: week 12

  2. Proportion of patients achieving 50% improvement of rash at 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.

    Measured: week 12

  3. Percentage change from body surface area at baseline to week 2, 4, 8 and 12

    Calculation of the affected body surface area as a percentage.

    Measured: baseline, week 2, 4, 8 and 12

  4. Proportion of patient reported outcome: Itch Numerical Rating Scale (Itch NRS)

    Itch Numerical Rating Scale (Itch NRS): 2 questions, rating the itch intensity on a scale from 0 to 10 points

    Measured: baseline, week 2, 4, 8 and 12

  5. Proportion of patient reported outcome: Dermatology Life Quality Index (DLQI)

    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

    Measured: baseline, week 2, 4, 8 and 12

  6. Proportion of patient reported outcome: Treatment Satisfaction Questionnaire for Medication (TSQM)

    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

    Measured: baseline, week 2, 4, 8 and 12

  7. Proportion of patient reported outcome: Five Well-Being Index (WHO-5)

    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

    Measured: baseline, week 2, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2024
  2. Study start10 Oct 2024
  3. Primary completion22 Apr 2026
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective single-center pilot study
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06399029
Sponsor's protocol ID
2023-01779
Other IDs
2023
Acronym
TRUX-LST
Status last verified
Apr 2026
First submitted
25 Apr 2024
Last updated
30 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib Topical Cream in people with Exanthema and Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients achieving at least 90% improvement of rash at week 12. (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06399029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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