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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 and week 6
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years or older and have signed the consent form.
Select...
My skin condition is moderate to severe and affects my face.
Select...
I have tried at least one treatment for my condition without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 and week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigator Global Assessment of 0 or 1 at Week 4
Secondary outcome measures
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
+7 moreTrial 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
858 Previous Clinical Trials
524,241 Total Patients Enrolled
1 Trials studying Seborrheic Dermatitis
66 Patients Enrolled for Seborrheic Dermatitis
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,120 Total Patients Enrolled
Benjamin Ungar, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
66 Total Patients Enrolled
1 Trials studying Seborrheic Dermatitis
66 Patients Enrolled for Seborrheic Dermatitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, will use effective birth control during the study, and for 90 days after.I do not have any major health issues that could affect my participation in the study.I have tried at least one treatment for my condition without success.I have not had a skin infection in the last 2 weeks.I have not taken any immune-suppressing drugs in the last 4 weeks.My skin condition is moderate to severe and affects my face.I haven't used any skin creams like steroids or calcineurin inhibitors in the last week.I have been treated with JAK inhibitors before.I am 18 years or older and have signed the consent form.You are not eligible if your skin condition is not severe enough based on the clinical severity and severity score.You have skin conditions that could affect the study assessments according to the doctor.I haven't taken strong CYP3A4 inhibitors recently.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Control Subjects
- Group 2: Ruxolitinib Cream
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a possibility of enrollment in this trail at present?
"This clinical trial is still recruiting participants, as evidenced by the fact it was recently updated on March 15th 2023. It was initially posted to clinicaltrials.gov on November 15 2020."
Answered by AI
How many participants have joined this clinical experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical investigation, which was initially publicized on November 15th 2022 is actively recruiting participants. 25 patients will be recruited from a single site for the trial's duration."
Answered by AI
Has the FDA authorized Ruxolitinib Cream for sale?
"There is evidence that Ruxolitinib Cream could be safe, which merits a score of 2. However, there are no studies yet to prove its efficacy in clinical settings."
Answered by AI
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