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Ruxolitinib in Seborrheic Dermatitis

Primary Purpose

Seborrheic Dermatitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib 1.5% Cream
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria For SD Subjects: 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. Inclusion Criteria For Control Subjects: 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 For SD Subjects: 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 Exclusion Criteria For Control Subjects: 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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ruxolitinib Cream

Healthy Control Subjects

Arm Description

Participants will receive topical ruxolitinib 1.5% cream

Age- and gender-matched healthy control subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in seborrheic dermatitis severity score from baseline to week 4
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)
Change in seborrheic dermatitis severity score for Scale from baseline to week 4
Scale 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Change in seborrheic dermatitis severity score for Erythema from baseline to week 4
Erythema 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Change in seborrheic dermatitis severity score for Pruritus from baseline to week 4
Pruritus 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Change in seborrheic dermatitis severity score from baseline to 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)
Change in seborrheic dermatitis severity score from week 4 to 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)
Frequency of Adverse Events
Duration of Adverse Events
Severity of Adverse Events
Severity will be measured as a category (mild, moderate, or severe).

Full Information

First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05787860
Brief Title
Ruxolitinib in Seborrheic Dermatitis
Official Title
Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment Response to Ruxolitinib 1.5% Cream
Study Type
Interventional

2. Study Status

Record Verification Date
March 8, 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrheic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-Label Trial
Masking
None (Open Label)
Masking Description
Open-Label
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib Cream
Arm Type
Active Comparator
Arm Description
Participants will receive topical ruxolitinib 1.5% cream
Arm Title
Healthy Control Subjects
Arm Type
No Intervention
Arm Description
Age- and gender-matched healthy control subjects
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 1.5% Cream
Intervention Description
topical ruxolitinib 1.5% cream twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Investigator Global Assessment of 0 or 1 at Week 4
Description
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
Time Frame
At end of Treatment, Week 4
Secondary Outcome Measure Information:
Title
Change in Investigator Global Assessment from baseline to week 4
Description
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
Time Frame
Baseline and Week 4
Title
Change in seborrheic dermatitis severity score from baseline to week 4
Description
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)
Time Frame
Baseline and Week 4
Title
Change in seborrheic dermatitis severity score for Scale from baseline to week 4
Description
Scale 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Time Frame
Baseline and Week 4
Title
Change in seborrheic dermatitis severity score for Erythema from baseline to week 4
Description
Erythema 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Time Frame
Baseline and Week 4
Title
Change in seborrheic dermatitis severity score for Pruritus from baseline to week 4
Description
Pruritus 0-4, where higher scores indicate more severe outcomes. (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = severe)
Time Frame
Baseline and Week 4
Title
Change in seborrheic dermatitis severity score from baseline to week 6
Description
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)
Time Frame
Baseline to Week 6
Title
Change in seborrheic dermatitis severity score from week 4 to week 6
Description
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)
Time Frame
Week 4 and Week 6
Title
Frequency of Adverse Events
Time Frame
Baseline to Week 6
Title
Duration of Adverse Events
Time Frame
Baseline to Week 6
Title
Severity of Adverse Events
Description
Severity will be measured as a category (mild, moderate, or severe).
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria For SD Subjects: 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. Inclusion Criteria For Control Subjects: 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 For SD Subjects: 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 Exclusion Criteria For Control Subjects: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Ungar, MD
Phone
212-241-3288
Email
Benjamin.Ungar@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giselle K Singer, BS
Phone
212-241-3288
Email
giselle.singer@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Ungar, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giselle K Singer, BS
Phone
212-241-3288
Email
giselle.singer@mssm.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Ungar

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be provided as aggregated data.

Learn more about this trial

Ruxolitinib in Seborrheic Dermatitis

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