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Janus Kinase (JAK) Inhibitor

Ruxolitinib Cream for Seborrheic Dermatitis

Phase 2
Waitlist Available
Led By Benjamin Ungar, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects ≥ 18 years of age at the time of signing the informed consent document
Baseline SD score of IGA ≥ 3 with facial involvement
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 and week 6
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if a drug can treat seborrheic dermatitis and compare it to healthy subjects.

Who is the study for?
Adults with seborrheic dermatitis (SD) who haven't responded to standard treatments like antifungals or low-potency steroids can join. They must have a moderate SD severity, not use other SD treatments during the trial, and be in good health. Women of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
The trial is testing Ruxolitinib cream's effectiveness on seborrheic dermatitis by comparing immune responses before and after treatment over four weeks. It's an open-label study, meaning everyone knows they're getting the actual drug without any placebos involved.
What are the potential side effects?
Ruxolitinib may cause side effects such as application site reactions, headaches, itching, or infections due to its immune-modifying actions. Since it affects the immune system, there might also be risks of more serious infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older and have signed the consent form.
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My skin condition is moderate to severe and affects my face.
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I have tried at least one treatment for my condition without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health issues that could affect my participation in the study.
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I have been treated with JAK inhibitors before.
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I haven't taken strong CYP3A4 inhibitors recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Investigator Global Assessment of 0 or 1 at Week 4
Secondary study objectives
Change in Investigator Global Assessment from baseline to week 4
Change in seborrheic dermatitis severity score for Erythema from baseline to week 4
Change in seborrheic dermatitis severity score for Pruritus from baseline to week 4
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Healthy Control SubjectsActive Control1 Intervention
Age- and gender-matched healthy control subjects
Group II: Ruxolitinib CreamActive Control1 Intervention
Participants will receive topical ruxolitinib 1.5% cream

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,722 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
391 Previous Clinical Trials
63,756 Total Patients Enrolled
Benjamin Ungar, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Ruxolitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05787860 — Phase 2
Dandruff Research Study Groups: Healthy Control Subjects, Ruxolitinib Cream
Dandruff Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT05787860 — Phase 2
Ruxolitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05787860 — Phase 2
~15 spots leftby Nov 2025
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