Seborrheic Dermatitis
Conditions
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.
Interventions
topical ruxolitinib 1.5% cream twice daily for 4 weeks
Sponsors
Incyte Corporation
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-Label
Intervention model description
Open-Label Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4 | At end of Treatment, 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Seborrheic Dermatitis Severity Score | Baseline, Week 4, Week 6 | 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) |
| Mean Change in Seborrheic Dermatitis Severity Score for Scale | Baseline, Week 4, and Week 6 | 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) |
| Change in Seborrheic Dermatitis Severity Score for Erythema | Baseline, Week 4, and Week 6 | 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) |
| Change in Investigator Global Assessment From Baseline to Week 4 | Baseline and 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 |
| Frequency of Adverse Events | 6 weeks | — |
| Duration of Adverse Events | 6 weeks | — |
| Severity of Adverse Events | 6 weeks | Severity will be measured as a category (mild, moderate, or severe). |
| Change in Seborrheic Dermatitis Severity Score for Pruritus | Baseline Week 4, and Week 6 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitinib Cream Ruxolitinib 1.5% Cream: topical ruxolitinib 1.5% cream twice daily for 4 weeks | 25 |
| Healthy Control Subjects Age- and gender-matched healthy control subjects | 20 |
| Total | 45 |
Baseline characteristics
| Characteristic | Total | Ruxolitinib Cream | Healthy Control Subjects |
|---|---|---|---|
| Age, Continuous | 45 years | 46 years | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 11 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 14 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 29 Participants | 14 Participants | 15 Participants |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 27 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 20 |
| other Total, other adverse events | 0 / 25 | 0 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 20 |
Outcome results
Primary
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
Time frame: At end of Treatment, Week 4
Population: Data collected only for participants with SD
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ruxolitinib Cream | Number of Participants With Investigator Global Assessment of 0 or 1 at Week 4 | 20 Participants |
Secondary
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
Time frame: Baseline and Week 4
Population: Data collected only for participants with SD
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ruxolitinib Cream | Change in Investigator Global Assessment From Baseline to Week 4 | -2.16 score on a scale | Standard Deviation 0.69 |
Secondary
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)
Time frame: Baseline, Week 4, and Week 6
Population: Data collected only for participants with SD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Erythema | week 4 and week 6 | 0.96 mean change in score on a scale | Standard Deviation 0.98 |
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Erythema | baseline and week 4 | -2 mean change in score on a scale | Standard Deviation 0.76 |
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Erythema | baseline and week 6 | -1.04 mean change in score on a scale | Standard Deviation 1.06 |
Secondary
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)
Time frame: Baseline Week 4, and Week 6
Population: Data collected only for participants with SD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Pruritus | baseline and week 4 | -2.44 mean change in score on a scale | Standard Deviation 0.71 |
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Pruritus | baseline and week 6 | -1.2 mean change in score on a scale | Standard Deviation 1.12 |
| Ruxolitinib Cream | Change in Seborrheic Dermatitis Severity Score for Pruritus | week 4 and week 6 | 1.24 mean change in score on a scale | Standard Deviation 0.97 |
Secondary
Duration of Adverse Events
Time frame: 6 weeks
Population: As there were no adverse events, duration could not be calculated.
Secondary
Frequency of Adverse Events
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ruxolitinib Cream | Frequency of Adverse Events | 0 events |
| Healthy Control Subjects | Frequency of Adverse Events | 0 events |
Secondary
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)
Time frame: Baseline, Week 4, Week 6
Population: Data collected only for participants with SD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score | baseline and week 4 | -6 mean change in score on a scale | Standard Deviation 1.61 |
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score | baseline and week 6 | -2.8 mean change in score on a scale | Standard Deviation 2.96 |
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score | week 4 and week 6 | 3.2 mean change in score on a scale | Standard Deviation 2.52 |
Secondary
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)
Time frame: Baseline, Week 4, and Week 6
Population: Data collected only for participants with SD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score for Scale | baseline and week 4 | -1.56 mean change in score on a scale | Standard Deviation 0.87 |
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score for Scale | baseline and week 6 | -0.56 mean change in score on a scale | Standard Deviation 1.29 |
| Ruxolitinib Cream | Mean Change in Seborrheic Dermatitis Severity Score for Scale | week 4 and week 6 | 3.2 mean change in score on a scale | Standard Deviation 2.52 |
Secondary
Severity of Adverse Events
Severity will be measured as a category (mild, moderate, or severe).
Time frame: 6 weeks
Population: As there were no adverse events, severity of adverse events could not be calculated.