Ruxolitinib in Seborrheic Dermatitis

NCT ID: NCT05787860

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-01-26

Brief Summary

This study is an open-label prospective interventional trial that will assess the efficacy of ruxolitinib in the treatment of seborrheic dermatitis. It will also attempt to characterize the molecular immune profiles of patients with SD at week 0 and week 4, with comparison to baseline profiles in healthy control subjects.

Detailed Description

The study will include 25 adult patients with moderate-to-severe-SD as well as 20 age- and gender-matched healthy control subjects for comparison. The SD patients will have baseline clinical score of at least 6 using the SD Severity Score in Appendix 1, or an Investigator Global Assessment (IGA) score of at least 3. Enrolled SD subjects will apply topical ruxolitinib 1.5% cream twice daily for 4 weeks. They will return for visits at weeks 2, 4, and 6 following study treatment initiation for repeat clinical assessments, medication reviews, tape-strip, blood and urine sample collections, and monitoring for adverse events.

Conditions

Seborrheic Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ruxolitinib Cream

Participants will receive topical ruxolitinib 1.5% cream

Group Type: ACTIVE_COMPARATOR

Ruxolitinib 1.5% Cream

Intervention Type: DRUG

topical ruxolitinib 1.5% cream twice daily for 4 weeks

Healthy Control Subjects

Age- and gender-matched healthy control subjects

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ruxolitinib 1.5% Cream

topical ruxolitinib 1.5% cream twice daily for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
• Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
• Subject is able to adhere to the study visit schedule and other protocol requirements.
• Baseline SD score of IGA ≥ 3 with facial involvement
• Subject agrees to discontinue all treatments for SD from screening through study completion aside from the study drug
• Subject has failed an adequate course of treatment with at least one available therapy (topical antifungals or low-potency topical corticosteroids)
• Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on the study drug and for at least 90 days after the last application of the study drug, male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

• Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR:
• Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

The female subject's chosen form of contraception must be effective by the time the female subject is enrolled into the study.

• Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
• Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
• Subject does not currently have and does not have a history of SD.
• Female of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

• SD clinical severity of IGA <3 and SD Severity Score <6.
• Subjects with other skin diseases that would interfere with the study assessment in the opinion of the investigator.
• Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
• Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases (e.g., malignancy, TB, HIV, HBV, HCV, thromboembolic events) that will affect the health of the subject during the study, or interfere with the interpretation of study results.
• Subject has previously received treatment with oral or topical JAK inhibitors
• Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors) within 1 week of baseline
• Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation
• Concurrent use of strong CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer). A list of CYP3A4 inhibiting medications can be found in Appendix 3.
• History of adverse systemic or allergic reactions to any component of the study drug.
• Current participation in any other study with an investigational medication
• Subject who is pregnant or breast feeding

• Active bacterial, fungal, or viral skin infection within 2 weeks from Screening/Baseline visit.
• Subject has uncontrolled clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other disease.
• Subject has previously received treatment with oral or topical JAK inhibitors
• Current other topical treatments (e.g., topical corticosteroids, topical calcineurin inhibitors) within 1 week of baseline
• Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus within 4 weeks of study initiation
• Current participation in any other study with an investigational medication
• Subject who is pregnant or breast feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Ungar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Ungar, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GCO 22-0672

Identifier Type: -

Identifier Source: org_study_id