AzTrials
AzTrials

Seborrheic DermatitisPhase 2NCT05787860

Ruxolitinib in Seborrheic Dermatitis

A Phase 2 study testing Ruxolitinib 1.5% Cream in people with Seborrheic Dermatitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Seborrheic Dermatitis
What is being tested?
Ruxolitinib 1.5% Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
15 Nov 2022to 26 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment Response to Ruxolitinib 1.5% Cream

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.

Read the 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.

Being tested
Ruxolitinib 1.5% Cream
Medical subject headings
Dermatitis, Seborrheic

What participants receive

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

  • Ruxolitinib 1.5% CreamDrug

    topical ruxolitinib 1.5% cream twice daily for 4 weeks

Study groups in NCT05787860
Study groupRoleWhat they receive
Ruxolitinib CreamActive comparatorParticipants will receive topical ruxolitinib 1.5% cream
Receives: Drug: Ruxolitinib 1.5% Cream
Healthy Control SubjectsNo interventionAge- and gender-matched healthy control subjects

What is being measured

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

  1. Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4

    Number of Participants with Investigator Global Assessment of 0 or 1 at Week 4

    IGA Scale from 0-4

    Clear 0 No signs of SD

    Almost Clear 1 Just perceptible erythema and just perceptible scaling

    Mild 2 Mild erythema and mild scaling

    Moderate 3 Moderate erythema and moderate scaling

    Severe 4 Severe erythema and severe scaling

    Measured: At end of Treatment, Week 4

Secondary outcomes (8)

  1. Change in Investigator Global Assessment From Baseline to Week 4

    IGA Scale from 0-4

    Clear 0 No signs of SD

    Almost Clear 1 Just perceptible erythema and just perceptible scaling

    Mild 2 Mild erythema and mild scaling

    Moderate 3 Moderate erythema and moderate scaling

    Severe 4 Severe erythema and severe scaling

    Measured: Baseline and Week 4

  2. Mean Change in Seborrheic Dermatitis Severity Score

    Mean Change in seborrheic dermatitis severity score from baseline and week 4, baseline a d week 6 and week 4 and week 6

    SD Severity Score (the sum of the three clinical features for a total score ranging from 0-12), where higher scores indicate more severe outcomes.

    Scale 0-4 Erythema 0-4 Pruritus 0-4 (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

    Measured: Baseline, Week 4, Week 6

  3. Mean Change in Seborrheic Dermatitis Severity Score for Scale

    Mean Change in seborrheic dermatitis severity score for Scale from baseline and week 4, baseline and week 6, week 4 and week 6

    Scale 0-4, where higher scores indicate more severe outcomes.

    (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

    Measured: Baseline, Week 4, and Week 6

  4. Change in Seborrheic Dermatitis Severity Score for Erythema

    Change in seborrheic dermatitis severity score for Erythema from baseline and week 4, baseline and week 6, week 4 and week 6

    Erythema 0-4, where higher scores indicate more severe outcomes.

    (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

    Measured: Baseline, Week 4, and Week 6

  5. Change in Seborrheic Dermatitis Severity Score for Pruritus

    Change in seborrheic dermatitis severity score for Pruritus from baseline and week 4, baseline and week 6, week 4 and week 6

    Pruritus 0-4, where higher scores indicate more severe outcomes.

    (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)

    Measured: Baseline Week 4, and Week 6

  6. Frequency of Adverse Events

    Measured: 6 weeks

  7. Duration of Adverse Events

    Measured: 6 weeks

  8. Severity of Adverse Events

    Severity will be measured as a category (mild, moderate, or severe).

    Measured: 6 weeks

Timeline

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

  1. First posted28 Mar 2023
  2. Study start15 Nov 2022
  3. Primary completion26 Jan 2024
  4. Study completion26 Jan 2024

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
Non-randomised
Intervention model
Single group
Model description
Open-Label Trial
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787860
Sponsor's protocol ID
GCO 22-0672
Status last verified
May 2025
First submitted
15 Mar 2023
Last updated
6 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Results will be provided as aggregated data.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib 1.5% Cream in people with Seborrheic Dermatitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

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 15 inclusion and 19 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: finished, as of the sponsor's last update on 6 May 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4 (time frame: At end of Treatment, Week 4). 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 NCT05787860.

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 6 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in