Clinical trial NCT05787860
Conditions: Seborrheic Dermatitis
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2022-11-15; Completion date: 2024-01-26
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

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.

Arms: arm 1: Participants will receive topical ruxolitinib 1.5% cream arm 2: Age- and gender-matched healthy control subjects
Interventions: intervention 1: Ruxolitinib 1.5% Cream
Intervention descriptions: intervention 1: topical ruxolitinib 1.5% cream twice daily for 4 weeks

Protocol documents:
Prot_SAP_000.pdf: 
Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment
Response to Ruxolitinib 1.5% Cream
PI: Benjamin Ungar, MD
NCT05787860
Document Date: 12/2/2022


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
1
Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and 
Treatment Response to Ruxolitinib 1.5% Cream
Principal Investigator:
Benjamin Ungar, MD
Emma Guttman, MD, PhD
Investigators:
Joel Correa da Rosa, PhD 
Study Site:
Icahn School of Medicine at Mount Sinai
Department of Dermatology and The Immunology Institute
5 East 98 Street, 5th Floor, Box 1048
New York, NY 10029
Protocol Version:
March 15, 2021
Amendment #1:
May 25, 2022
Amendment #2:
October 24, 2022
Effective Date: 12/2/2022
End Date:7/27/2023


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Table of Contents
Background  …………………………………......
3
Treatment Rationale…………………................
3
Hypothesis……………………….…….………....
4
Objectives……………………….….…..………...
4
Endpoints………………………..……………......
4
Study Design Overview………………................
5
Mechanistic Analyses……………….…..............
6
Patient Population 
Inclusion Criteria…………………….…....
6
Exclusion Criteria…………………….…...
7
Potential Risks of Ruxolitinib 1.5% Cream…….
9
Prior Treatment………………………...………...
9
Prohibited Treatment………………………….....
9
Procedures……………………………………......
10
Safety Monitoring……………………..…………..
13
Study Withdrawal……………………..….............
13
Discontinuation of Treatment and 
Withdrawal of Subjects……………..........
13
Subject Identification……………………………..
15
Study Drug Supply……………...........................
15
Statistical Considerations………………………..
16
Table 1. Schedule of Events………….………...
19
References……………………………….............
20
Appendix 1. Clinical Assessments…...………...
22
Appendix 2. Dermatology Life Quality Index…...
23
Appendix 3. CYP3A4 Inhibitors…………………
25
Appendix 4. Study Drug Label…………………..
26
Appendix 5. Amendment Details………….…….
27
Effective Date: 12/2/2022
End Date:7/27/2023


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BACKGROUND:
Seborrheic dermatitis (SD) is a very common skin condition affecting tens of millions of 
Americans, with over $300 million spent annually on over-the-counter treatment 
products (1, 2). Clinically, it is characterized by erythematous, yellowish scaly plaques in 
the scalp, eyebrows, ears, forehead, nasolabial folds, chest, axillae, and inguinal areas 
(3). The pathophysiology of SD is not well understood, with three general factors 
believed to play a role: Malassezia colonization, increased production of lipids by 
sebaceous glands, and immune abnormalities (4). SD is also more common in men, 
implicating androgens as a contributing factor. Current clear treatment guidelines are 
lacking, with some evidence to support topical antifungals (5) and broad-acting topical 
anti-inflammatory treatments such as steroids and calcineurin inhibitors (6), and non-
pharmacological approaches also used (7). That these treatments have been shown to 
be better than placebo support the contributions of both Malassezia and immune 
dysregulation in the pathophysiology of the disease. However, as long-term use of 
steroids is contraindicated, alternative topical approaches are needed and remain under 
investigation (8, 9). The immune dysregulation underlying SD has not been well 
characterized, but upregulation of several cytokines and cytokine pathways have been 
suggested, including Th1, Th2, Th17, (i.e., IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-
12, IL-17, TNF-α, and IFN-γ) (10-12). Furthermore, treatment of SD with anti-
inflammatory agents such as crisaborole has shown some promise in early studies (9).
TREATMENT RATIONALE:
Current treatments for SD center around topical antifungals, based on the role that 
Malassezia is believed to play in disease pathogenesis, and anti-inflammatory agents 
such as topical steroids, which are broad-acting and cannot be applied chronically due to 
the risk of multiple side effects (11). The pathogenesis of SD is poorly understood, but 
dysregulated immune markers from different pathways have been suggested, including 
Th1, Th2, Th17, (i.e., IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12, IL-17, TNF-α, and 
IFN-γ).
Ruxolitinib is an inhibitor JAK1 and JAK2 signaling, which suppresses the majority of the 
proposed SD-related cytokines simultaneously. In experimental models of dermatitis, 
ruxolitinib cream successfully reduced itch and down-regulated multiple inflammatory 
pathways (13). Although modulation of molecular biomarkers with application of ruxolitinib 
cream is lacking in humans, clinical efficacy has been shown in the Th2-driven disease 
atopic dermatitis in phase 2 (14) and phase 3 (15) studies, demonstrating the ability to 
normalize the pathogenic immune dysregulation in atopic dermatitis as well as in a phase 
2 study of vitiligo (16), in which Th1 signaling is believed to play a major role. Furthermore 
topical approaches with immunomodulatory medications in SD [e.g., crisaborole (9)] have 
been used in small studies, supporting this approach.
Therefore, we hypothesize that topical ruxolitinib cream will be able to reverse the 
immune dysregulation seen in SD, leading to clinical improvement.
Effective Date: 12/2/2022
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HYPOTHESIS:
Primary Hypothesis

Twice daily application of ruxolitinib 1.5% cream for 4 weeks will be clinically 
efficacious in treating moderate-to-severe seborrheic dermatitis.
OBJECTIVES:
Primary Objectives

To characterize the clinical responses to treatment with topical ruxolitinib 1.5% 
cream applied twice daily for 4 weeks in moderate-to-severe SD patients.
Secondary Objectives

To characterize the molecular cutaneous phenotype of SD.

To compare molecular biomarker expression in SD patients with healthy controls.

To characterize the molecular responses to treatment with topical ruxolitinib 1.5% 
cream applied twice daily for 4 weeks in moderate-to-severe SD patients.

To correlate the molecular and clinical responses to treatment with topical 
ruxolitinib 1.5% cream applied twice daily in order to identify biomarkers of 
treatment response in SD patients

To validate a clinical SD disease severity score using assessments by two 
independent investigators

To evaluate the safety and tolerability of topical ruxolitinib 1.5% cream applied 
twice daily for 4 weeks in moderate-to-severe SD patients
ENDPOINTS:
Primary Endpoint

The proportion of patients who achieve an IGA 0/1 at 4 weeks of treatment with 
ruxolitinib 1.5% cream applied twice daily
Secondary Endpoints

Change from baseline in IGA score at 4 weeks of treatment with ruxolitinib 1.5% 
cream applied twice daily

Change from baseline in overall clinical SD score at 4 weeks of treatment with 
ruxolitinib 1.5% cream applied twice daily
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
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
Change from baseline in each component of the clinical SD score at 4 weeks of 
treatment with ruxolitinib 1.5% cream applied twice daily (scale, erythema, pruritus)

Change in overall clinical SD at 6 weeks (i.e., 2 weeks after treatment cessation) 
from baseline and from 4 weeks

The frequency, duration, and severity of AEs

Changes in vital signs

Changes in laboratory data for hematology, serum chemistry, and urinalysis
Mechanistic (Exploratory) Endpoints

Determine the molecular cutaneous phenotype of SD at baseline compared with 
healthy controls, using transcriptomic and proteomic approaches from skin 
samples acquired by tape-strips

Identify molecular markers that correlate with disease activity in SD at baseline 

Characterize the change in molecular responses with treatment of topical 
ruxolitinib 1.5% cream after 4 weeks of treatment

Identify molecular markers that correlate with treatment response at 4 weeks
STUDY DESIGN OVERVIEW:
This study is an open-label prospective interventional trial. The study will take place at 
Icahn School of Medicine at Mount Sinai.  
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. 
After providing consent, all subjects will be assessed for study eligibility, which includes 
a review of the subjects past and current medical conditions, familial medical history and 
detailed review of past and current medications. SD subjects will also undergo a review 
of past topical treatments/therapies for SD, and clinical assessments (clinical SD score 
and IGA). 
Subjects who meet inclusion criteria for eligibility may continue with the Baseline Visit 
(Week 0) or can be scheduled to return for the Baseline Visit within 28 days of the 
Screening Visit. 
SD Subjects: 
Effective Date: 12/2/2022
End Date:7/27/2023


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At Baseline/Week 0, subjects will undergo clinical assessments (clinical SD Severity 
Score and IGA), review of concomitant medications, standardized clinical photography, 
and a Dermatology Life Quality index (DLQI) questionnaire (Appendix 2). Subsequent 
clinical assessments including standardized clinical photography, and questionnaire 
completion will be performed at follow up visits at Week 2, Week 4, and Week 6. Skin 
tape-strip samples will be collected for mechanistic studies (described below) at baseline 
(lesional and non-lesional facial skin), Week 2 (lesional facial skin), Week 4 (lesional facial 
skin), and Week 6 (lesional facial skin). Additional blood samples will be collected and 
stored at baseline and at Week 4 (or early termination, whichever is first) for potential 
future mechanistic analyses.
Control Subjects:
At Baseline/Week 0, subjects will undergo a review of concomitant medications, skin 
tape-strip samples will be collected for mechanistic studies (described below) of non-
lesional facial skin, blood and urine sample collection for standard laboratory testing, and 
a blood sample for possible future mechanistic analyses.
MECHANISTIC ANALYSES:
We will characterize the molecular immune profiles of patients with SD at week 0 and 
week 4, with comparison to baseline profiles in healthy control subjects.
We plan to obtain lesional and non-lesional tape strip samples from facial skin of SD 
patients at week 0 and lesional facial skin samples at Week 4 (Primary Endpoint). 
Additionally, lesional facial skin samples will be collected at Week 2 and Week 6 and 
stored for potential future analysis. Blood samples at baseline and at Week 4 will be 
collected and stored for potential future analysis.
Gene expression studies on tape strip samples will be performed using Illumina NovaSeq 
6000 for RNA-seq, and proteomic studies on tape strip samples will be performed using 
the Olink Explore panel, which includes >1,500 protein analytes.
PATIENT POPULATION:
Prior to enrollment, all subjects must meet the following inclusion and exclusion criteria:
Inclusion Criteria For SD Subjects:
1)
Male or female subjects ≥ 18 years of age at the time of signing the informed 
consent document.
2)
Subject is able to understand and voluntarily sign an informed consent document 
prior to participation in any study assessments or procedures.
Effective Date: 12/2/2022
End Date:7/27/2023


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3)
Subject is able to adhere to the study visit schedule and other protocol 
requirements.
4)
Baseline SD score of IGA ≥ 3 with facial involvement
5)
Subject agrees to discontinue all treatments for SD from screening through study 
completion aside from the study drug
6)
Subject has failed an adequate course of treatment with at least one available 
therapy (topical antifungals or low-potency topical corticosteroids)
7)
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).
8)
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.
Exclusion Criteria For SD Subjects:
The presence of any of the following will exclude a subject from enrollment:
1)
SD clinical severity of IGA <3 and SD Severity Score <6.
Effective Date: 12/2/2022
End Date:7/27/2023


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2)
Subjects with other skin diseases that would interfere with the study assessment 
in the opinion of the investigator.
3)
Active bacterial, fungal, or viral skin infection within 2 weeks from study initiation.
4)
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.
5)
Subject has previously received treatment with oral or topical JAK inhibitors
6)
Current other topical treatments (e.g., topical corticosteroids, topical calcineurin 
inhibitors) within 1 week of baseline
7)
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
8)
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.
9)
History of adverse systemic or allergic reactions to any component of the study 
drug.
10) Current participation in any other study with an investigational medication
11) Subject who is pregnant or breast feeding
 
Inclusion Criteria For Control Subjects:
1)
Male or female subjects ≥ 18 years of age at the time of signing the informed 
consent document.
2)
Subject is able to understand and voluntarily sign an informed consent document 
prior to participation in any study assessments or procedures.
3)
Subject does not currently have and does not have a history of SD. 
4)
Female of childbearing potential (FCBP) must have a negative pregnancy test at 
Screening and Baseline
Effective Date: 12/2/2022
End Date:7/27/2023


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Exclusion Criteria For Control Subjects:
1) Active bacterial, fungal, or viral skin infection within 2 weeks from 
Screening/Baseline visit.
2)
Subject has uncontrolled clinically significant (as determined by the investigator) 
renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, 
neurological, psychiatric, immunologic, or other disease. 
3)
Subject has previously received treatment with oral or topical JAK inhibitors
4)
Current other topical treatments (e.g., topical corticosteroids, topical calcineurin 
inhibitors) within 1 week of baseline
5)
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
6)
Current participation in any other study with an investigational medication
7)
Subject who is pregnant or breast feeding
POTENTIAL RISKS OF RUXOLITINIB 1.5% CREAM:
Based on phase 2 and phase 3 studies in atopic dermatitis, as well as phase 2 studies in 
vitiligo, topical application of ruxolitinib 1.5% cream shows a good safety profile. The most 
commonly experienced adverse events in the atopic dermatitis studies were application 
site burning and pruritus, which occurred more commonly in the vehicle control group 
(15). These results were mirrored in the phase 2 vitiligo study, with the additional 
observation of 18% of vitiligo patients experienced development of acne as a treatment-
related adverse event (16). Although oral ruxolitinib has been associated with the risk of 
hematologic abnormalities in patients treated for polycythemia vera or myelofibrosis, 
pharmacokinetic analysis performed in the phase 3 studies in atopic dermatitis patients 
with up to 20% body surface area involvement demonstrated plasma ruxolitinib 
concentrations substantially lower than those required for systemic activity (17). 
PRIOR TREATMENT:
All relevant treatment received by the subject within 30 days before screening will be 
recorded. 
PROHIBITED TREATMENT: 
Effective Date: 12/2/2022
End Date:7/27/2023


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All treatments prohibited during the screening period are also prohibited throughout the 
course of the study. All subjects treated previously with a topical or oral JAK inhibitor will 
be excluded from the study as above.
PROCEDURES:
Monitoring of Aes will begin at the time of signing the informed consent form and will be 
continued throughout the course of the study. All study procedures will be completed at 
designated times during the study period (see Table 1).
Trained assessors will perform clinical assessments. It is strongly recommended that the 
same assessor/s perform clinical assessments for a subject at all study visits.
For SD Subjects
Visit 1 – Screening (within 28 days of Baseline)* 

Obtain signed IRB-approved informed consent and HIPPA agreement

Review Inclusion and Exclusion Criteria

Record gender, race, ethnicity, and medical history

Review personal and family history of SD and other inflammatory skin diseases

Record all concomitant medications as well as all those received within 30 days 
prior to screening

Record all prior therapies for SD

Urine pregnancy test for all female subjects of child-bearing potential 

SD Clinical assessments (IGA, SD Severity Score)

Record adverse events
* If subject meets all entry criteria at Screening, he/she can complete Baseline Visit 
on the same day (identical procedures do not need to be repeated). If more than 28 
days has lapsed between screening and Baseline/Visit 2, then all procedures should 
be repeated except for re-obtaining informed consent. If subject has used a topical 
medication, then Baseline/Visit 2 will occur only after a 1 week washout period.
Visit 2 – Baseline (Week 0)

Confirm all inclusion and exclusion criteria have been met

Record concomitant medications and adverse events

DLQI questionnaire

Standardized clinical photography (including photographs of subject’s entire face 
and close up photographs of the following facial regions: 1. Left cheek, 2. Right 
cheek, 3. Forehead and glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all female subjects of child-bearing potential 
Effective Date: 12/2/2022
End Date:7/27/2023


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
Collect blood samples for CBC with differential, Comprehensive metabolic panel 
(CMP), and C-reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

Perform tape strips of lesional and non-lesional skin. Lesional skin tape strips will 
be taken from area of worst clinical involvement

Dispense/administer study drug
Visit 3 – Week 2

Record concomitant medications and adverse events

DLQI questionnaire

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all female subjects of child-bearing potential 

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the 
same location as the lesional tape strips taken at Baseline.

Dispense study drug and assess compliance. Subjects will report each study drug 
application, with 4 missed doses from Baseline considered non-compliance.
Visit 4 – Week 4

Record concomitant medications and adverse events

DLQI questionnaire

Standardized clinical photography (including photographs of subject’s entire face 
and close up photographs of the following facial regions: 1. Left cheek, 2. Right 
cheek, 3. Forehead and glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all female subjects of child-bearing potential 

Collect blood samples for CBC with differential, Comprehensive metabolic panel 
(CMP), and C-reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the 
same location as the lesional tape strips taken at Baseline and Week 2.

Assess study drug dosing compliance and retrieve all remaining study drug from 
subject. Subjects will report each study drug application, with 4 missed doses from 
Week 2 considered non-compliance. 
Visit 5 – Week 6

Record concomitant medications and adverse events

DLQI questionnaire
Effective Date: 12/2/2022
End Date:7/27/2023


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
Standardized clinical photography including photographs of subject’s entire face 
and close up photographs of the following facial regions: 1. Left cheek, 2. Right 
cheek, 3. Forehead and glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all female subjects of child-bearing potential 

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the 
same location as the lesional tape strips taken at Baseline, Week 2, and Week 4.
Early Termination Visit (if applicable)

Record concomitant medications and adverse events

DLQI questionnaire

Standardized clinical photography (including photographs of subject’s entire face 
and close up photographs of the following facial regions: 1. Left cheek, 2. Right 
cheek, 3. Forehead and glabella)

Urine pregnancy test for all female subjects of child-bearing potential 

Collect blood samples for CBC with differential, Comprehensive metabolic panel 
(CMP), and C-reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

SD clinical assessments (IGA, SD Severity Score)

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the 
same location as the lesional tape strips taken at Baseline and Week 2 (if 
applicable)

Assess study drug dosing compliance and retrieve all remaining study drug from 
subject 
For Control Subjects
Visit 1 – Screening (within 28 days of Baseline)* 

Obtain signed IRB-approved informed consent and HIPPA agreement

Review Inclusion and Exclusion Criteria

Record gender, race, ethnicity, and medical history

Review personal and family medical conditions/diseases

Record all concomitant medications as well as all those received within 30 days 
prior to screening

Urine pregnancy test for all female subjects of child-bearing potential 

Record adverse events
* If subject meets all entry criteria at Screening, he/she can complete Baseline Visit 
on the same day (identical procedures do not need to be repeated). If more than 28 
days has lapsed between screening and Baseline/Visit 2, then all procedures should 
be repeated except for re-obtaining informed consent.
Effective Date: 12/2/2022
End Date:7/27/2023


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Visit 2 – Baseline (Week 0)

Confirm all inclusion and exclusion criteria have been met

Record concomitant medications and adverse events

Urine pregnancy test for all female subjects of child-bearing potential 

Collect blood samples for CBC with differential, Comprehensive metabolic panel 
(CMP), and C-reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

Perform tape strips of non-lesional skin
SAFETY MONITORING:
The study will be conducted in accordance with our department’s Standard Operating 
Procedures, which are based on US FDA Title 21 Code of Federal Regulations and ICH 
Good Clinical Practice guidelines. An investigator will review all laboratory results and 
assess for adverse events. The principal investigator will be informed of all adverse 
events. In the event that a subject’s safety is compromised, the investigator will 
discontinue the subject immediately.
STUDY WITHDRAWAL:
In the event a study subject wants to withdraw early from the study for any reason, the 
subject will be asked to return for a final visit to have some or all of the following 
procedures and assessments as listed for Visit 5/Week 6: vital signs; blood test; 
pregnancy test (if applicable); clinical photography; SD clinical assessments; DLQI 
questionnaire, assessment of concomitant medication and adverse events; blood 
collection for future mechanistic analysis; lesional tape strip collection. 
DISCONTINUATION OF TREATMENT AND WITHDRAWAL OF SUBJECTS:
The reasons why a subject may discontinue or be withdrawn from the study by the 
investigator include, but are not limited to the following: subject request, protocol 
violation, loss to follow up, subject non-compliance,  defined as 4 missed applications 
during the 2 week period between study Visits, study termination by investigators, and a 
confirmed grade 3 or higher adverse event, which is suspected to be related to study 
drug administration. Subjects that elect to withdraw from the trial due to lack of efficacy 
and/or exacerbation of disease will undergo the following: vital signs; blood test; 
pregnancy test (if applicable); clinical photography; SD clinical assessments; DLQI 
questionnaire, assessment of concomitant medication and adverse events; blood 
collection for future mechanistic analysis; lesional tape strip collection. 
Stopping Rules
Patients will be permanently discontinued from study treatment in the event of:
Effective Date: 12/2/2022
End Date:7/27/2023


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
Anaphylactic reaction or other severe systemic reaction to study drug application 

Pregnancy at anytime during the study period 

Diagnosis of a malignancy during study, excluding carcinoma in situ of the cervix, 
or squamous or basal cell carcinoma of the skin

Any infection that is opportunistic, whose nature or course may suggest an 
immuno-compromised status

Treatment with any prohibited concomitant medication or procedure

Other reasons that may lead to the permanent discontinuation of study drug 
include certain Aes deemed related to the study drug.

If the following lab results are abnormal, participants will be retested in a window 
of 7-10 days and reassessed. If the test results remain abnormal, participants will 
be discontinued from the study:
Hematology
Absolute Neutrophil Count:<1000/mm3; <1.0 x109/L
Hemoglobin:  <8.0 g/dL; <4.96 mmol/L; <80 g/L
Hemoglobin drop ≥2 g/dL from baseline on two consecutive blood draws with 
associated symptoms; or hemoglobin drop ≥3 g/dL from baseline on two 
consecutive blood draws without associated symptoms. 
Platelet count: <75,000/mm3; <75.0x109/L
Lymphocytes: <500/mm3; <0.5x109/L
Chemistry
AST >3.0x ULN
ALT >3.0x ULN
Total bilirubin >1.5x ULN
CPK >10x ULN
Total bilirubin ≥1.5 x ULN; subjects with a history of Gilbert's syndrome may have 
a direct bilirubin measured and would be eligible for this study provided the direct 
bilirubin is  ULN

Other intercurrent illnesses or major surgery

An infection that requires systemic treatment with antibiotic, antifungal, antiviral, 
anti-parasitic, or anti-protozoal agents or requires oral treatment with such agents 
for longer than 2 weeks

Treatment with systemic corticosteroids or non-steroidal immunosuppressive/ 
immunomodulating medications (e.g., cyclosporine, methotrexate, azathioprine, 
mycophenalate-mofetil, Janus kinase inhibitors, biologic agents, etc.).
Safety Evaluation
Safety and tolerability will be evaluated from the Aes, physical examinations, and vital 
sign measurements. More frequent safety evaluations may be performed if clinically 
indicated or at the discretion of the investigator.
Aggregated Aes will be evaluated by the PI/research teams. The local IRB, FDA, and 
Incyte will be notified of adverse events.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
15
The Principal Investigator (PI) must report all Serious Adverse Events (SAEs) to Incyte 
within 24 hours of learning of an event, regardless of the PI’s causality assessment. 
This notification should be provided on a completed Serious Adverse Event (SAE) form.  
SAE reporting for each subject begins the day the informed consent is signed by the 
patient and within 14 days after subject has completed or discontinued from the study or 
has taken last dose of the study drug, or as described in the protocol.
SAEs, occurring using Incyte study drug, are reported in accordance with the effective 
protocol.  SAEs occurring with any other commercial drug are reported to the 
manufacturer of that drug in accordance with regulations and protocol. 
Initial SAEs and/or subsequent follow-up reports should be reported via email to 
SafetyReporting@Incyte.com  or fax (+) 1-866-981-2057.  SAE reports should be for a 
single subject.  SAE forms should be sent with a cover sheet and any additional 
attachments.
All adverse event information is reported to Incyte on the Principal 
Investigator’s/Institution’s Adverse Event Report Form, or a CIOMS-I or MedWatch 
Form FDA 3500A, or on an Adverse Event Report Form which may be provided by 
Incyte upon request. The Principal Investigator does not provide medical records (e.g., 
discharge summary) to Incyte, unless specifically requested.
 
Reporting of Pregnancy to Incyte
An “Initial Pregnancy Report” or equivalent must be completed in full and emailed to 
SafetyReporting@Incyte.com or faxed to (+) 1-866-981-2057 within 24 hours of discovery 
of a pregnancy of a subject who has taken the Incyte product or the pregnancy of a partner 
for a subject who has taken the Incyte product.  The “Follow-up Pregnancy Report Form” 
or equivalent must be completed and emailed to SafetyReporting@Incyte.com or faxed 
to (+) 1-866-981-2057 within 30 days after delivery, so that Incyte is provided with 
information regarding the outcome of the pregnancy.  If the pregnancy results in any 
events which meet the serious criteria (i.e., miscarriage or termination), the SAE reporting 
process needs to be followed and the timelines associated with a SAE should be followed.
SUBJECT IDENTIFICATION
Subjects are numbered sequentially. Each subject will be assigned a unique screening 
number for the duration of the study. Subject screening numbers will not be reassigned 
or reused for any reason. The investigator must maintain a master log linking the subject 
number to the subject’s name. The investigator must follow all applicable privacy laws in 
order to protect a subject’s privacy and confidentiality. 
STUDY DRUG SUPPLY:
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
16
Eligible patients will receive a supply of ruxolitinib 1.5% cream which they will apply to 
affected skin on the face only twice daily. Patients will be instructed not to use more than 
60g of cream per week.
All study medication will be stored in a secure cool area between 15-30°C. Study drug will 
be provided to subjects at each study visit, with initial application performed at that time 
and subsequent applications performed by the patients at home. 
Subjects will be queried during each study visit on any missed applications.
STATISTICAL CONSIDERATIONS:
Sample Size Calculation
A sample size of n=20 SD patients guarantees 90% power at 2.1% significance to detect 
a minimum proportion of 75% of patients with IGA 0/1 at week 4. This calculation assumes 
the application of the one-sided binomial test with a null hypothesis proportion of 40%. 
This proportion is based on the vehicle response benchmark reported by Zirwas et 
al.(2021)  when comparing IGA 0/1 at week 8 in 154 patients treated with roflumilast foam 
0.3% vs. 72 patients in the vehicle-controlled group(18). Accounting for a 20% dropout 
rate, we, therefore, propose a sample size of n=25 patients. 
Mechanistic Endpoint
To the best of our knowledge, this is the first study to evaluate differences in the 
transcriptome between SD and healthy subjects. A previous study (19) evaluated a fold-
change (FCH) of 5 in IL-10 cell counts with coefficient of variation of 50% when comparing 
10 SD subjects to 4 healthy volunteers. Assuming similar variability, a sample size of n = 
20 SD subjects and n= 20 controls would provide 90% power at 5% significance to detect 
FCH>2.65 when comparing IL-10 expression between SD and controls, based on a two-
sided unpaired t-test applied to log2-transformed RNA-seq data and fold-changes back 
transformed. 
Demographics and Other Baseline Characteristics
Descriptive statistics of demographics and other baseline characteristics of patients will 
be summarized. Other baseline characteristics include height, weight, vital signs, duration 
of SD disease, concurrent diagnoses from medical history and indications for concomitant 
medication, concomitant medication, and previous SD treatments.
Analysis of Primary Endpoint
The one-sided binomial test will be used to verify the hypothesis that the proportion of 
patients achieving IGA 0/1 at 4 weeks of treatment with ruxolitinib 1.5% cream applied 
twice daily is greater than 0.4.
Analysis of Secondary Endpoints
The two-sided Wilcoxon signed-rank test will assess the significance of changes from 
baseline in:  
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
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17

IGA score at 4 weeks of treatment

Components of clinical SD scoring (scale, erythema, and pruritus) at 4 
weeks of treatment.
The two-sided paired t-test will assess the significance of changes from baseline in: 

Overall clinical SD scoring at 4 and 6 weeks of treatment.

Vital signs measured in interval or ratio scale 

Analytes measured in interval or ratio scale from laboratory tests 
(hematology, serum, chemistry, and urinalysis) at 4 weeks of treatment
The p-values will be adjusted by the Bonferroni method. The frequency, duration, and 
severity of AEs will be summarized with tables and summary statistics.
Analysis of Mechanistic (Exploratory) Endpoints
The baseline immune and molecular cutaneous profile of SD at baseline compared with 
healthy controls and the change in the immune and molecular cutaneous profile of SD 
with treatment will be assessed by MMRM approach. Gene/Protein expression data will 
be modeled using a mixed effect model with the interaction between tissue type (non-
lesional/ lesional / healthy) and timepoint as fixed effects and a random effect for each 
subject. 
RNA-sequencing data will be profiled by Illumina NovaSeq 6000. RNA-sequencing data 
will be pre-processed using standard quality control metrics, such as FastQC and 
MultiQC, sequence alignment by STAR RNA-sequencing aligner and sequencing reads 
assignment to genomic features by featureCounts, followed by voom-transform. Mixed 
effect models will be used on R’s limma framework and p-values for the moderated t-tests 
and paired-t-test will be adjusted by Benjamini-Hochberg procedure. Extensive 
bioinformatics tools will be employed to gain insights into the results. This will include (but 
will not be limited to) pathway and gene-set enrichment analyses by R package GSVA 
(Gene Set Variation Analysis) and by eXploring Genomic Relations (XGR) that uses prior 
biological knowledge and relationships from public databases.
We will perform proteomic biomarker studies in serum using the OLINK high-throughput 
proteomic platform, with the Explore panel that evaluates >1,500 protein analytes. Protein 
expression data will be modeled using a MMRM approach, with the interaction of study 
group (treatment /control) and timepoint as fixed effects and a random effect for each 
subject.
We will use the Spearman coefficient to correlate: 1) molecular markers with disease 
activity in SD at baseline; 2) changes from baseline in molecular markers with changes 
from baseline in IGA and overall clinical SD scoring at 4 weeks of treatment.
Data Transfer and Management
Data including the patient info, demographics, clinical scores and treatment allocation 
code will be sent to our Biostatistical Team in password-protected files. 
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
18
Data from the Guttman Lab (where all mechanistic studies will be done), including 
sequencing data and proteomics will be deposited in the Mount Sinai Box, which has the 
necessary safeguards for protection of human subjects research.
All data management steps taken to reformat and merge the clinical and laboratory data 
will be carried out using R codes, so all the steps of the processes can be reproduced. 
Management of the Analysis 
Analyses will be run in our desktops, with a backed-up copy in the Mount Sinai Box 
account. Once the analysis is finalized, all data will be deposited into the central file 
storage system (CFS), which is accessible to all research members. Both Mount Sinai 
Box and the CFS have backup capabilities and are encrypted and password protected. 
Analysis of Safety and Tolerability
Safety will be evaluated by tabulations of adverse events (AEs) and will be presented with 
descriptive statistics at each visit. AEs will be coded using the CTCAE, Common 
Terminology Criteria for Adverse Events, V 5.0. The number and percentage of 
subjects/lesions experiencing an AE/SAE will be stratified by system organ class, or a 
preferred term, and/or severity of the adverse event, and recorded and tabulated overall 
by each sub-strata. Each subject will be counted only once within a system organ class 
or a preferred term using the adverse events with the highest severity within each 
category. All information pertaining to adverse events noted during the study will be listed 
by subject, detailing verbatim given by the investigator, preferred term, system organ 
class, date of onset, date of resolution, severity, and relationship to treatment. A 
tabulation of AEs will be provided by subject. 
DLQI (Dermatology Life Quality Index)
The DLQI is a validated questionnaire consisting of 10 questions that has been used in 
many randomized controlled trials in dermatology (20, 21).
Scoring
The scoring of each question is as follows:
Very much
scored 3
A lot
scored 2
A little
scored 1
Not at all
scored 0
Not relevant
scored 0
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
19
The DLQI is calculated by summing the score of each question. The maximum score is 
30 and minimum score is 0. Higher score represents a quality of life that is more 
impaired.
Definition of DLQI Scores
0-1 = no effect at all on patient's life 
2-5 = small effect on patient's life 
6-10 = moderate effect on patient's life 
11-20 = very large effect on patient's life 
21-30 = extremely large effect on patient's life
A change in DLQI score of at least 4 points is considered clinically important (22). Such 
change suggests that there has actually been a meaningful change in that patient's 
quality of life since the previous measurement of his/her DLQI scores.
Question unanswered
scored 0
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
20
Table 1. Schedule of Events  
Visit Week
(Up to -28 
Days before 
Baseline)
0
2
4
6
X
Control 
Subjects
Visit #
1
2
3
4
5
Early 
Term-
ination 
1
Visit Type
Screening
Baseline
Tx
Tx
F-up
Screening 
/ Baseline
 
Informed Consent
X
X
Inclusion / Exclusion
Criteria
X
X3
X
Demographics and Medical Hx1
X
X
Urine Pregnancy Test
X
X3
X
X
X
X
X
CBC w/differential; CMP;  
Urinalysis
X
X
X
X
Blood Sample Stored for Future 
Analysis
X
X
X
X
CRP
X
X
X
SD Clinical Assessments 
(IGA, SD Severity Score)
X
X3
X
X
X
X
Dermatology Life Quality Index 
(DLQI)
X
X
X
X
X
Standardized Photographs
X
X
X
X
Dispense Drug
X
X
Assess Application Compliance
X
X
X
Lesional Tape Strip
X
X
X
X
X
Non-lesional Tape Strip
X
X
Concomitant Medications
X2
X3
X
X
X
X
X
Adverse Events
X
X3
X
X
X
X
X
1 Includes current and past medical conditions in addition to personal and family history of inflammatory
   skin diseases
2 Includes prior therapies/treatments for SD and any medications received within 30 days of screening. 
3 Does not need to be repeated if Screening and Baseline occur on the same day.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
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REFERENCES:
1.
Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A 
Comprehensive Review. J Clin Investig Dermatol. 2015;3(2).
2.
Manuel F, Ranganathan S. A new postulate on two stages of dandruff: a clinical 
perspective. International journal of trichology. 2011;3(1):3-6.
3.
Naldi L, Rebora A. Clinical practice. Seborrheic dermatitis. The New England 
journal of medicine. 2009;360(4):387-96.
4.
Adalsteinsson JA, Kaushik S, Muzumdar S, Guttman-Yassky E, Ungar J. An 
update on the microbiology, immunology and genetics of seborrheic dermatitis. 
Experimental dermatology. 2020;29(5):481-9.
5.
Okokon EO, Verbeek JH, Ruotsalainen JH, Ojo OA, Bakhoya VN. Topical 
antifungals for seborrhoeic dermatitis. The Cochrane database of systematic reviews. 
2015(5):CD008138.
6.
Kastarinen H, Okokon EO, Verbeek JH. Topical anti-inflammatory agents for 
seborrheic dermatitis of the face or scalp: summary of a Cochrane Review. JAMA 
dermatology. 2015;151(2):221-2.
7.
Piquero-Casals J, Hexsel D, Mir-Bonafe JF, Rozas-Munoz E. Topical Non-
Pharmacological Treatment for Facial Seborrheic Dermatitis. Dermatol Ther (Heidelb). 
2019;9(3):469-77.
8.
Piquero-Casals J, La Rotta-Higuera E, Francisco Mir-Bonafe J, Rozas-Munoz E, 
Granger C. Non-Steroidal Topical Therapy for Facial Seborrheic Dermatitis. Journal of 
drugs in dermatology : JDD. 2020;19(6):658-60.
9.
Pena SM, Oak ASW, Smith AM, Mayo TT, Elewski BE. Topical crisaborole is an 
efficacious steroid-sparing agent for treating mild-to-moderate seborrhoeic dermatitis. 
Journal of the European Academy of Dermatology and Venereology : JEADV. 
2020;34(12):e809-e12.
10.
Schwartz JR, Messenger AG, Tosti A, Todd G, Hordinsky M, Hay RJ, et al. A 
comprehensive pathophysiology of dandruff and seborrheic dermatitis - towards a more 
precise definition of scalp health. Acta dermato-venereologica. 2013;93(2):131-7.
11.
Wikramanayake TC, Hirt P, Almastadi M, Mitchell H, Tomic-Canic M, Romero L, 
et al. Increased IL-17-expressing gammadelta T cells in seborrhoeic dermatitis-like 
lesions of the Mpzl3 knockout mice. Experimental dermatology. 2018;27(12):1408-11.
12.
Wikramanayake TC, Borda LJ, Miteva M, Paus R. Seborrheic dermatitis-Looking 
beyond Malassezia. Experimental dermatology. 2019;28(9):991-1001.
13.
Scuron MD, Fay BL, Connell AJ, Peel MT, Smith PA. Ruxolitinib Cream Has Dual 
Efficacy on Pruritus and Inflammation in Experimental Dermatitis. Frontiers in 
immunology. 2020;11:620098.
14.
Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME, et al. Treatment of 
atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. The 
Journal of allergy and clinical immunology. 2020;145(2):572-82.
15.
Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Leung DYM, et al. 
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Atopic Dermatitis: Results 
From Two Phase 3, Randomized, Double-Blind Studies. Journal of the American 
Academy of Dermatology. 2021.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
March 25, 2022
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16.
Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, et al. 
Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 
2020;396(10244):110-20.
17.
Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, et al. Pharmacokinetics 
of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from 
Phase II and III Studies. American journal of clinical dermatology. 2021;22(4):555-66.
18.
M Z, ZD D, J D, L K, A M, L SG, et al. Efficacy and safety of roflumilast foam 0.3% 
in patients with seborrheic dermatitis in a randomized, double-blind, vehicle-controlled 
phase 2 study. JAAD. 2021;85(3).
19.
Faergemann J, Bergbrant IM, Dohse M, Scott A, Westgate G. Seborrhoeic 
dermatitis and Pityrosporum (Malassezia) folliculitis: characterization of inflammatory 
cells and mediators in the skin by immunohistochemistry. The British journal of 
dermatology. 2001;144(3):549-56.
20.
Le Cleach L, Chassany O, Levy A, Wolkenstein P, Chosidow O. Poor reporting of 
quality of life outcomes in dermatology randomized controlled clinical trials. Dermatology. 
2008;216(1):46-55.
21.
Both H, Essink-Bot ML, Busschbach J, Nijsten T. Critical review of generic and 
dermatology-specific health-related quality of life instruments. J Invest Dermatol. 
2007;127(12):2726-39.
22.
Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal 
clinically important difference and responsiveness of the Dermatology Life Quality Index 
(DLQI): further data. Dermatology. 2015;230(1):27-33.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
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Appendix 1. Clinical Assessments
SD Severity Score
a0-4 for each clinical feature (0 = absence, 1 = mild, 2 = moderate, 3 = significant, 4 = 
severe)
Investigator Global Assessment
Clinical Feature
Scorea
Scale
0-4
Erythema
0-4
Pruritus
0-4
Total Score
0-12
Clinical severity
Scored
Features
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
Effective Date: 12/2/2022
End Date:7/27/2023


S e b orr h eic D er m atitis R ux oliti ni b Cr e a m Pr ot oc ol
I nc yt e II R
Oct o b er 2 4, 2 0 2 2
2 4
A p p e n di x 2.
D er m at ol o g y Lif e Q u alit y I n d e x
T h e ai m of t hi s q u e sti o n n air e i s t o m e a s ur e h o w m u c h y o ur s ki n pr o bl e m h a s aff e ct e d 
y o ur lif e O V E R T H E L A S T W E E K.  Pl e a s e c h e c k o n e b o x f or e a c h q u e sti o n.
1.
O v er t h e l a st w e e k, h o w it c h y, s or e , p ai nf ul  or 
sti n gi n g  h a s y o ur s ki n b e e n ?
V er y m u c h
A l ot
A littl e
N ot at all




2.
O v er t h e l a st w e e k, h o w e m b arr a s s e d  or s elf 
c o n s ci o u s  h a v e y o u b e e n b e c a u s e of y o ur s ki n ?
V er y m u c h
A l ot
A littl e
N ot at all




3.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n 
i nt erf er e d wit h y o u g oi n g s h o p pi n g  or l o o ki n g 
aft er y o ur h o m e  or y ar d ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
4.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n 
i nfl u e n c e d t h e cl ot h e s  y o u w e ar ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
5.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n 
aff e ct e d a n y s o ci al  or l ei s ur e a cti viti e s ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
6.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n m a d e 
it diffi c ult f or y o u t o d o a n y s p ort ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
O v er t h e l a st w e e k, h a s y o ur s ki n pr e v e nt e d y o u 
fr o m w or ki n g  or st u d yi n g ?
y e s
n o


N ot r el e v a nt 
7.
If " N o", o v er t h e l a st w e e k h o w m u c h h a s y o ur s ki n 
b e e n a pr o bl e m at w or k  or st u d yi n g ?
A l ot
A littl e
N ot at all 



Eff e cti v e D at e: 1 2/ 2/ 2 0 2 2
E n d D at e: 7/ 2 7/ 2 0 2 3


S e b orr h eic D er m atitis R ux oliti ni b Cr e a m Pr ot oc ol
I nc yt e II R
Oct o b er 2 4, 2 0 2 2
2 5
8.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n 
cr e at e d pr o bl e m s wit h y o ur p art n er  or a n y of y o ur 
cl o s e fri e n d s or r el ati v e s? 
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
9.
O v er t h e l a st w e e k, h o w m u c h h a s y o ur s ki n 
c a u s e d a n y s e x u al diffi c ulti e s ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
1 0. O v er t h e l a st w e e k, h o w m u c h of a pr o bl e m h a s t h e 
tr e at m e nt f or y o ur s ki n b e e n, f or e x a m pl e b y 
m a ki n g y o ur h o m e m e s s y, or b y t a ki n g u p ti m e ?
V er y m u c h
A l ot
A littl e
N ot at all




N ot r el e v a nt 
Eff e cti v e D at e: 1 2/ 2/ 2 0 2 2
E n d D at e: 7/ 2 7/ 2 0 2 3


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
26
Appendix 3 CYP3A4 Inhibitors.
CYP3A4 Inhibitors
Amiodarone
Indinavir
Amprenavir
Isavuconazole
Aprepitant
Itraconazole
Atazanavir
Ketoconazole
Boceprevir
Lopinavir
Casopitant
Mibefradil
Cimetidine
Mifepristone (RU486)
Ciprofloxacin
Nefazodone
Clarithromycin
Nelfinavir
Cobicistat
Netupitant
Conivaptan
Nilotinib
Crizotinib
Norfloxacin
Cyclosporine
Norfluoxetine
Danoprevir
Posaconazole
Darunavir
Ritonavir
Delavirdine
Saquinavir
Diltiazem
Schisandra sphenanthera
Dronedarone
Telaprevir
Elvitegravir
Telithromycin
Erythromycin
Tipranavir
Faldaprevir
Tofisopam
Fluconazole
Troleandomycin
Gestodene
Verapamil
Grapefruit Juice, marmalade
Viekira pak
Idelalisib
Voriconazole
Imatinib
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
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Appendix 4 – Study Drug Label
                         
                          Department of Dermatology
                                       212-241-3288
GCO#22-0672 Seborrheic Dermatitis and Treatment Response to 
Ruxolitinib 1.5% Cream
Subject #________  Subject Initials:___________  Date:__________
Ruxolitinib 1.5% Cream - Apply as directed by the study doctor
PI: Dr Benjamin Ungar  (212) 241-3288.
Store at controlled room temperature, away from light and humidity.
Caution: New Drug--Limited by Federal (USA) law to investigational use.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
28
Appendix 5. Amendment Details
Amendment #1 May 25, 2022
Page 1 – Title Page – Added Amendment #1: May 25, 2022; Revised Date of protocol in footer.
Page 2 Table of Contents – Revised Page numbers and added Subject Identification and 
Appendices 3, 4 and 5.
Page 7 Inclusion Criteria for SD Subjects – Removed SD Severity Score as a criterion and added 
inclusion criterion: “Subject has failed an adequate course of treatment with at least one available 
therapy (topical antifungals or low-potency topical corticosteroids).”
Page 8 Exclusion Criteria for SD Subjects – Added Exclusion criterion: “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.”
Page 14 Stopping Rules – Added the following stopping rules:

If the following lab results are abnormal, participants will be retested in a window of 7-10 
days and reassessed. If the test results remain abnormal, participants will be 
discontinued from the study:
Hematology
Absolute Neutrophil Count:
<1000/mm3; <1.0 x109/L
Hemoglobin:  <8.0 g/dL; <4.96 mmol/L; <80 g/L
Hemoglobin drop ≥2 g/dL from baseline on two consecutive blood draws with associated 
symptoms; or hemoglobin drop ≥3 g/dL from baseline on two consecutive blood draws 
without associated symptoms. 
Platelet count: <75,000/mm3; <75.0x109/L
Lymphocytes: <500/mm3; <0.5x109/L
Chemistry
AST >3.0x ULN
ALT >3.0x ULN
Total bilirubin >1.5x ULN
CPK >10x ULN
Total bilirubin ≥1.5 x ULN; subjects with a history of Gilbert's syndrome may have a 
direct bilirubin measured and would be eligible for this study provided the direct bilirubin 
is  ULN

Other intercurrent illnesses or major surgery

An infection that requires systemic treatment with antibiotic, antifungal, antiviral, anti-
parasitic, or anti-protozoal agents or requires oral treatment with such agents for longer 
than 2 weeks

Treatment with systemic corticosteroids or non-steroidal immunosuppressive/ 
immunomodulating medications (e.g., cyclosporine, methotrexate, azathioprine, 
mycophenalate-mofetil, Janus kinase inhibitors, biologic agents, etc.).
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
29
Page 22 Appendix 1. Clinical Assessments – added a description of features associated with 
the individual scores of the Investigator Global Assessment.
Page 25 – Added Appendix 3 CYP3A4 Inhibitors
Page 26 – Added Appendix 4 Study Drug Label
Page 27 – Added Appendix 5 Amendment Details
Amendment #2 - October 24, 2022
Page 1 – Title Page – Added Amendment #2: October 24, 2022; Revised Date of protocol in 
footer.
Page 4 – Primary Endpoint
Revised from: “Percent of patients who achieve an IGA of 0 or 1 at 4 weeks of treatment 
with ruxolitinib 1.5% cream applied twice daily”
To: “The proportion of patients who achieve an IGA 0/1 at 4 weeks of treatment with 
ruxolitinib 1.5% cream applied twice daily”
Page 16 - Sample Size Calculation
Revised from: “30 moderate-to-severe patients treated with crisaborole for four weeks 
showed 67.8% average improvement in IGA with a standard deviation of approximately 
50% (9). Assuming similar biological variation (sd = 50%), a sample size of n=20 SD 
patients provides 95% power at 5% significance to detect a minimum average 
improvement in IGA of 42.5% with the application of a two-sided paired t-test. Accounting 
for a 20% dropout rate, we, therefore, propose a sample size of n=25 patients.”
To: “A sample size of n=20 SD patients guarantees 90% power at 2.1% significance to 
detect a minimum proportion of 75% of patients with IGA 0/1 at week 4. This calculation 
assumes the application of the one-sided binomial test with a null hypothesis proportion 
of 40%. This proportion is based on the vehicle response benchmark reported by Zirwas 
et al.(2021)  when comparing IGA 0/1 at week 8 in 154 patients treated with roflumilast 
foam 0.3% vs. 72 patients in the vehicle-controlled group(18). Accounting for a 20% 
dropout rate, we, therefore, propose a sample size of n=25 patients. “
Page 16 - Analysis of Primary Endpoint
Revised from “A Mixed-effects ordinal logistic regression model will be used to test 
differences in IGA between time points with time (Weeks 0, 2, 4, and 6) as a fixed effect, 
a random intercept for subjects, and inclusion of baseline characteristics as covariates. “
To: “The one-sided binomial test will be used to verify the hypothesis that the proportion 
of patients achieving IGA 0/1 at 4 weeks of treatment with ruxolitinib 1.5% cream applied 
twice daily is greater than 0.4.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
30
Page 16 – Analysis of Secondary Endpoints
Revised from: “The mixed-effects model for continuous outcomes will also be used to 
detect any overall changes in clinical SD scoring over time compared with baseline with 
time (Weeks 0, 2, 4, and 6) as a fixed effect, a random intercept for subjects, and potential 
covariates. Changes in each component of the SD Severity Score, will also be evaluated 
using the same approach.” 
To: “The two-sided Wilcoxon signed-rank test will assess the significance of changes from 
baseline in:  

IGA score at 4 weeks of treatment

Components of clinical SD scoring (scale, erythema, and pruritus) at 4 weeks of 
treatment.
The two-sided paired t-test will assess the significance of changes from baseline in: 

Overall clinical SD scoring at 4 and 6 weeks of treatment.

Vital signs measured in interval or ratio scale 

Analytes measured in interval or ratio scale from laboratory tests (hematology, 
serum, chemistry, and urinalysis) at 4 weeks of treatment
The p-values will be adjusted by the Bonferroni method. The frequency, duration, and 
severity of AEs will be summarized with tables and summary statistics.”
 Page 17 - Analysis of Mechanistic (Exploratory) Endpoints
Revised from: “The baseline immune and molecular cutaneous profile of SD at baseline 
compared with healthy controls and the change in the immune and molecular cutaneous 
profile of SD with treatment will be assess by MMRM approach. Gene/Protein expression 
data will be modeled using a mixed effect model with tissue type and time as a fixed effect 
and a random effect for each subject.”
To: “The baseline immune and molecular cutaneous profile of SD at baseline compared 
with healthy controls and the change in the immune and molecular cutaneous profile of 
SD with treatment will be assessed by MMRM approach. Gene/Protein expression data 
will be modeled using a mixed effect model with the interaction between tissue type (non-
lesional/ lesional / healthy) and timepoint as fixed effects and a random effect for each 
subject.”
Revised from: “We will perform proteomic biomarker studies in serum using the OLINK 
high-throughput proteomic platform, with the Explore panel that evaluates >1,500 protein 
analytes. Protein expression data will be modeled using a MMRM approach, with time 
interaction as a fixed effect and a random effect for each subject.”
To: “We will perform proteomic biomarker studies in serum using the OLINK high-
throughput proteomic platform, with the Explore panel that evaluates >1,500 protein 
analytes. Protein expression data will be modeled using a MMRM approach, with the 
interaction of study group (treatment /control) and timepoint as fixed effects and a random 
effect for each subject.
Effective Date: 12/2/2022
End Date:7/27/2023


Seborrheic Dermatitis Ruxolitinib Cream Protocol
Incyte IIR
October 24, 2022
31
We will use the Spearman coefficient to correlate: 1) molecular markers with disease 
activity in SD at baseline; 2) changes from baseline in molecular markers with changes 
from baseline in IGA and overall clinical SD scoring at 4 weeks of treatment.”
Effective Date: 12/2/2022
End Date:7/27/2023

ICF_001.pdf: 
Characterizing the Molecular Cutaneous Phenotype of Seborrheic Dermatitis and Treatment 
Response to Ruxolitinib 1.5% Cream
PI: Benjamin Ungar
NCT05787860
Document Date: 7/28/2023


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 1 of 21
Study ID: STUDY-22-00546  
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
__________________________
STUDY INFORMATION:
Study Title: Characterizing the Molecular Cutaneous Phenotype of Seborrheic 
Dermatitis and Treatment Response to Ruxolitinib 1.5% Cream
Study site(s): Icahn School of Medicine at Mount Sinai
Lead Researcher (Principal Investigator): Benjamin Ungar, MD 
Physical Address: 
Icahn School of Medicine at Mount Sinai
Department of Dermatology and The Immunology Institute
5 East 98 Street, 5th Floor, Box 1048
New York, NY 10029
Mailing Address:
5 East 98 Street, 5th Floor, Box 1048
New York, NY 10029
Phone: 
212-241-3288
____________________________
SUMMARY OF THIS RESEARCH STUDY:
This document explains a research study you might be interested in joining.  Participation in the study 
is voluntary. You can agree to join or not. Your decision will not limit your ability to receive care at 
Mount Sinai. You should only agree to take part if you understand the study and if all of your 
questions about the research study are answered. If you do join the study, the research team must 
share any new information with you that may change your mind about taking part.
The purpose of this research study is to assess the effect and safety of ruxolitinib 1.5% cream on 
individuals and their Seborrheic dermatitis (SD) as well as to compare their response to age- and 
gender-matched healthy controls. At the conclusion of the trial, participants will be evaluated to 
determine if Ruxolitinib improves moderate-to-severe SD.
If you choose to take part, you will be asked your involvement in the study will last 7 weeks. During the 
time you are enrolled into this current study, you will not be able to participate in other research studies.
Prior to receiving any study treatment, you will undergo a screening visit in the Department of 
Dermatology Clinical Trials office at Mount Sinai Hospital to determine if you meet the qualifications for 
this study. The treatment group must have moderate-to-severe SD. The control comparison group must 
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 2 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
have no personal or family history of SD. If screening is successful, you will return to the clinic for up to 
four additional visits for those in the SD group, and only one visit for those in the control group, which 
will include a baseline visit that will serve as week 0. Throughout your study participation, the site staff 
will administer blood tests, urine analysis, urine pregnancy tests (for participants who have the potential 
to get pregnant), skin assessments, and patient questionnaires. To appropriately determine progression 
of treatment, there will be clinical photography of the area of your skin affected by SD. In order to 
participate in this study, you will also need to consent to skin tape-strip samples, which involves applying 
special tape to the skin and removing it to analyze. There will be no charge to you for your participation 
in this study. Individuals enrolled in this study will be compensated for their time and effort. The study 
drug, study related procedures, and study site visits will be provided at no charge to you or your 
insurance company. 
If you choose to take part, the main risks to you are burning where you apply the cream, itching and 
the development of acne.  
You may benefit from taking part in this research. Some potential benefits are: The findings from this 
study may help to identify new therapies for this disease. You may also benefit from participation in this 
research if the study drug improves your condition, or improves your quality of life.  
Instead of taking part in this research, you may take topical or oral antifungal medications or anti 
inflammatory medications
If you are interested in learning more about this study, please continue to read below.
____________________________
STUDY PARTICIPATION: 
You may qualify to take part in this research study because you have moderate-to-severe-SD or an age 
and gender-matched adult with no personal or familial history of SD.   
 
Your participation in this research study is expected to last approximately 7 weeks. 
There are 45 people expected to take part in this research study at Icahn School of Medicine at Mount 
Sinai. There will be 25 participants enrolled with seborrheic dermatitis and 20 control participants. 
Funds for conducting this research study are provided by Incyte Corporation, the manufacturer of 
ruxolitinib. 
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 3 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This website will not include information that can identify you. At most, the website will include a 
summary of the results. You can search this website at any time.
__________________________
DESCRIPTION OF WHAT IS INVOLVED:
If you agree to take part in this research study, here is what may be involved:
All research visits/activities will be performed only at the Icahn School of Medicine at Mount Sinai, 
Department of Dermatology. All procedures performed during the study are being done for research 
purposes only.
Visit 1 – Screening (within 28 days of Baseline) (approximately 1-2 hours) 

Obtain signed IRB-approved informed consent and HIPPA agreement

Review Inclusion and Exclusion Criteria

Record gender, race, ethnicity, and medical history

Review personal and family history of SD and other inflammatory skin diseases

Record all concomitant medications as well as all those received within 30 days prior to 
screening

Record all prior therapies for SD

Urine pregnancy test for all participants that have the potential to get pregnant  

SD Clinical assessments: Investigator Global Assessment (IGA) and SD Severity Score

Record adverse events
If you qualify for the study at screening, you can proceed to complete the Baseline visit on the same 
day.  Identical procedures will not be repeated if Screening and Baseline visits occur on the same day.
Visit 2 – Baseline (Week 0) (approximately 40 minutes)

Confirm all inclusion and exclusion criteria have been met

Record concomitant medications and adverse events

Dermatology Life Quality Index (DLQI) questionnaire

Standardized clinical photography (including photographs of participant’s entire face and close 
up photographs of the following facial regions: 1. left cheek, 2. right cheek, 3. forehead and 
glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all participants that have the potential to get pregnant  

Collect safety blood samples for Complete Blood Count (CBC) with differential, Comprehensive 
metabolic panel (CMP), and C-reactive protein (CRP) 
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 4 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)

Collect blood sample for possible future mechanistic analyses to compare molecular changes 
between those that have SD and those who do not. 

Urinalysis

Perform tape strips of lesional and non-lesional skin. Lesional skin tape strips will be taken from 
area of skin most affected by SD

Dispense/administer study drug
Visit 3 – Week 2

Record concomitant medications and adverse events

DLQI questionnaire

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all participants that have the potential to get pregnant  

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the same location 
as the lesional tape strips taken at Baseline.

Dispense study drug and assess compliance. 

Participants will report each study drug application. If you miss 4 doses from the first visit, you 
may be removed from participating in the study. 
Visit 4 – Week 4

Record concomitant medications and adverse events

DLQI questionnaire

Standardized clinical photography (including photographs of participant’s entire face and close 
up photographs of the following facial regions: 1. left cheek, 2. right cheek, 3. forehead and 
glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all participants that have the potential to get pregnant  

Collect blood samples for CBC with differential, Comprehensive metabolic panel (CMP), and C-
reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the same location 
as the lesional tape strips taken at Baseline and Week 2.

Dispense study drug and assess compliance. 

Participants will report each study drug application. If you miss 4 doses from the first visit, you 
may be removed from participating in the study. 
Visit 5 – Week 6 (Follow-up)

Record concomitant medications and adverse events
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 5 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)

DLQI questionnaire

Standardized clinical photography including photographs of participant’s entire face and close 
up photographs of the following facial regions: 1. left cheek, 2. right cheek, 3. forehead and 
glabella)

SD clinical assessments (IGA, SD Severity Score)

Urine pregnancy test for all participants that have the potential to get pregnant

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the same location 
as the lesional tape strips taken at Baseline, Week 2, and Week 4.
Early Termination Visit (if applicable)

Record concomitant medications and adverse events

DLQI questionnaire

Standardized clinical photography (including photographs of participant’s entire face and close 
up photographs of the following facial regions: 1. left cheek, 2. right cheek, 3. forehead and 
glabella)

Urine pregnancy test for all participants that have the potential to get pregnant  

Collect blood samples for CBC with differential, Comprehensive metabolic panel (CMP), and C-
reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

SD clinical assessments (IGA, SD Severity Score)

Perform tape strips of lesional skin. Lesional skin tape strips will be taken from the same location 
as the lesional tape strips taken at Baseline and Week 2 (if applicable)

Assess study drug dosing compliance and retrieve all remaining study drug from participant
For Control Participants
Visit 1 – Screening (within 28 days of Baseline)* 

Obtain signed IRB-approved informed consent and HIPPA agreement

Review Inclusion and Exclusion Criteria

Record gender, race, ethnicity, and medical history

Review personal and family medical conditions/diseases

Record all concomitant medications as well as all those received within 30 days prior to 
screening

Urine pregnancy test for all participants that have the potential to get pregnant  
* If participant meets all entry criteria at Screening, he/she can complete Baseline Visit on the same 
day (identical procedures do not need to be repeated). If more than 28 days has lapsed between 
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 6 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
screening and Baseline/Visit 2, then all procedures should be repeated except for re-obtaining 
informed consent.
Visit 2 – Baseline (Week 0)

Confirm all inclusion and exclusion criteria have been met

Record concomitant medications and adverse events

Urine pregnancy test for all participants that have the potential to get pregnant  

Collect blood samples for CBC with differential, Comprehensive metabolic panel (CMP), and C-
reactive protein (CRP) 

Collect blood sample for possible future mechanistic analyses

Urinalysis

Perform tape strips of non-lesional skin
Because this research study involves the use of a study drug, a note must be included in your 
electronic medical record that you are taking part in the research. This way, anyone involved in your 
medical care will know that you are a study participant, and they can work to avoid any problems or 
negative outcomes that could arise if they do not know.
HIV/AIDS
By law, positive test results for HIV/AIDS (as well as other communicable diseases such as hepatitis 
B, hepatitis C, and syphilis) are reported to the NYS Department of Health so they can study how 
people get and transmit the disease and notify sexual or needle-sharing partners they may have been 
exposed.  If you wish to be tested anonymously for HIV/AIDS, the research team can refer you to a 
public testing center, but you will not be able to be in this study. New York State law protects the 
confidentiality of HIV test results and other related information. It is illegal to discriminate against a 
person based on their HIV status and services are available to help if this happens. You are free to 
refuse to get an HIV test, but if you refuse you cannot be part of this research study.
Pregnancy
If you can possibly get pregnant, a urine test for pregnancy will be done before you begin the study 
and the pregnancy test will be repeated at every subsequent visit while using the study drug. 
You cannot be included in the study if you are or become pregnant, as the study drug could harm your 
fetus. You also should not be in the study if you are producing milk to feed a child as the study drug 
could harm your baby.
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 7 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
Unless you are at least one year past menopause or have had a successful operation to make 
pregnancy impossible, you should use effective birth control. Unless you are sexually abstinent (not 
having genital sex) the recommended methods of birth control are:

The consistent use of approved hormonal birth control (pill, patches, or rings), 

An intrauterine device (IUD), 

Contraceptive injection (Depo-Provera), 

Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), 

Sexual abstinence (no sexual activity), 

Sterilization (a vasectomy, getting tubes tied, or a hysterectomy).
All birth control methods (other than abstinence and sterilization) are only effective if you use them 
properly, start them at least one month before you begin the research study, and continue using them 
throughout the research study and for 28 days after the research study ends. If you are unsure 
whether the method of birth control you use is approved to use while you are in this study, you should 
ask the Lead Researcher before you begin the study. If you are less than one-year post-menopausal, 
you could still become pregnant. If you or your partner becomes pregnant, or may be pregnant, at any 
time, you must tell a person from the research team immediately. The team may stop the study drug 
and refer you/your partner to an obstetrician/gynecologist for follow-up. 
Should you/your partner become pregnant, whether or not you/your partner have the baby, the people 
funding and overseeing the research may ask for information on the pregnancy, even if you are no 
longer part of the study. You/your partner will be asked for additional written consent to share this 
information if that happens.
 
Semen/Sperm:
Drugs can be found in semen and alter sperm. Since you are taking part in a study using experimental 
drugs or treatments, it is recommended that 1) you use a condom, 2) you do not get a partner 
pregnant or expose them to semen, and 3) you do not donate semen.  These recommendations apply 
both while you are taking the study drug, and for 90 days after you stop taking the study drug. This is 
because levels of the study drug may be present in the sperm and/or semen even after you stop 
taking the study drug.  You are encouraged to tell your partner(s) and/or their doctor(s) that you are 
participating in this clinical trial.
____________________________
Future Contact: 
The researchers may wish to use your personal contact information to contact you in the future. Do 
you give the researchers permission to contact you in the future to request the collection of  
additional information about you, discuss how your private information, study data and/or samples 
might be used, or discuss possible participation in another research study? 
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 8 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
Please initial your choice: Yes_________ No__________
____________________________
USE OF YOUR DATA AND/OR SAMPLES:
The researchers would like your permission to keep your personal information (such as, name, 
address, date of birth, social security number), study data and/or samples (blood, tissue, urine, saliva, 
or any other body matter) to use or share in future studies. You can still be part of the study if you do 
not allow us to use or share them. Please select Yes or No to each of the questions below. To decline 
all future uses/sharing please select ‘No’ each time.
(1) Will you allow the researchers to store your data and/or samples to use in future research studies?
Please initial your choice: Yes________ No_________ 
If you select No, please stop here and move to the next section, 'Your Responsibilities If You Take 
Part in This Research' section below."
If yes, please continue to the next question and tell us how your personal information, study data 
and/or samples may be used in future research studies. 
(2) The researchers will store your data and/or samples in the following way:
a) Linked to your identity (using a code that can show the information came from you 
personally). In this case you could ask for your data and/or samples to be destroyed in the 
future if you want that to happen. 
I would like my data and/or samples stored with a link to my identity through the use of a code______
(3) Do you give the researchers permission to keep the data and/or samples, so they could use them 
in future studies that are directly related to the purpose of the current study?
Please initial your choice: Yes_________ No____________________
(4) Do you give the researchers permission to keep the data and/or samples indefinitely, so they could 
use them for future studies that are not related to the purpose of the current study (for example a 
different area of research)?   
Please initial your choice: Yes_________ No__________
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 9 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
(4.1) From time to time, researchers outside of medicine and related sciences would like to use data 
and/or samples. This might be in the fields such as anthropology, human origins, mapping human 
migration patterns. Do you give permission for researchers outside the field of medicine to use your 
data and/or samples? 
Please initial your choice: Yes_________ No__________
a.
If the future research in a different area can be done without having to know that the data and/or 
samples came from you personally, that will be done.  
b. If the future research in a different area requires that it is known specifically who the  data and/or 
samples came from, then one of the following will be done:
I.
If you allowed the researchers to contact you in the future, they may be able to contact you to 
explain why your data and/or samples is needed and what will be done with it. Your 
permission will be asked to use your data and/or samples in that research project.
II.
If you do not give permission to be contacted in the future, or if it is found that contacting you is 
not practical (for example, because you have moved), your data and/or samples may still be 
used. The Institutional Review Board (IRB) will be asked for permission to use the data and/or 
samples linked to your identity. The IRB can give permission for researchers to use and share 
identifiable health information without contacting you, but only if it determines that sharing the 
data and/or samples will not be more than minimal risk to you or your privacy. The IRB is a 
committee of doctors and scientists and nonscientists, including people not associated with 
this hospital or medical school, whose job it is to protect people who participate in research.
 
(5) Do you give permission to have your data and/or samples given to other researchers, including 
those at Mount Sinai, other medical or scientific institutions and for-profit companies, for use in 
research within the limits you have chosen above? 
Please initial your choice: Yes_________ No__________
(6) Do you give permission to have portions of your data and/or samples deposited in large public 
databases (repositories) for use in research with the limits you may have chosen above? Please read 
the paragraphs below which explains repositories, then initial your choice:
To do more powerful research, it is helpful for researchers to share data and/or samples from the 
people they study. They do this by putting data and/or samples into a repository. A repository is where 
something is stored safely for a specified period of time. Data and/or samples from one study may be 
stored in a repository along with data and/or samples from other studies. Sample repositories are 
commonly called biobanks, while data repositories are commonly called databases. . Researchers 
can then use the data and/or samples from multiple studies to learn even more about health and 
disease. If you agree to take part in this study, some of your genetic and health information might be 
placed into one or more scientific databases, but they will not share your direct identifiers (for 
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example, name, address, date of birth). These databases are maintained by either Icahn School of 
Medicine at Mount Sinai, another institution, the federal government, or private companies. Any 
researcher who wants to do a study using data and/or samples from the repository must apply for 
permission. There are different ways of reviewing such requests. Researchers with an approved study 
may be able to see and use your data, along with that from many other people. Researchers may use 
your samples for genetic sequencing and other experimental testing. Researchers will always have a 
duty to protect your privacy and to keep your information confidential, but there are always risks 
associated with data and/or sample collection and sharing. They are described in more detail in the 
Risks section.
Please initial your choice:  Yes ________    No _________
Whether or not you have allowed us to share your data and/or samples, the researchers at Mount 
Sinai will keep data and/or samples collected about you during this research study to use in future 
research studies consistent with the wishes you expressed above. 
  ____________________________
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH:
If you decide to take part in this research study, you will be responsible for the following things: 

While you are taking part in this study, you should not take part in another study without 
notifying the study doctor.  

You must follow the instructions you are given by the study doctor and study staff. If you do 
not follow the instructions, your visit may have to be rescheduled, or you may be discontinued 
from the study. 

Tell the study doctor or the study staff about all prescription and non-prescription medications, 
supplements, herbal preparations, or vaccines before you take them. 

Notify the study doctor or study staff if you move and provide your new address and contact 
information. 

Avoid becoming pregnant by adhering to the birth control methods outlined in Description of 
What’s Involved.
____________________________
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
There may be costs to you for taking part in this study. Certain safety tests or assessments may 
uncover underlying diseases or problems that require medical attention. 
If you agree to take part in this study, you will be paid $60 per visit for your time and effort, up to a 
total of $240 if you all complete all visits. You will not be compensated for the screening visit. If you do 
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not complete this study for any reason, you will be paid for the study visits you do complete. Payment 
will be given to you in the form of a check at the end of the study. 
It can take up to 8 weeks to prepare and give you a check for study participation. If you do not get a 
check by then, you can first contact the research team. If further assistance is needed, please contact 
Mount Sinai’s Program for the Protection of Human Subjects at (212) 824-8200.
Tax law may require the Mount Sinai Finance Department to report the amount of payment you 
receive from Mount Sinai to the Internal Revenue Service (IRS) or other agencies, as 
applicable. Generally, this happens if you receive payments that equal $600 or more from Mount Sinai 
in a calendar year.  You would be responsible for the payment of any tax that may be due.
It is possible that products may someday be developed with the help of your data and/or samples, and 
there are no plans to share any profits from such products with you.
____________________________
POSSIBLE BENEFITS:
There is a chance this study may benefit you, but this is not guaranteed. Others may benefit from 
what researchers learn from the study. Possible benefits to you include: improvement of your SD or 
your SD flare may be shorter. A study drug provided at no cost during a study may not be available for 
free, or at all, when the research ends. 
____________________________
POSSIBLE RISKS AND DISCOMFORTS:
Physical risks 
In addition to the risks below, this research may hurt you in ways that are not known.  The unknown 
risks might be minor or might be major (death).
There are risks to taking part in any research study. Side effects may occur. Some of those side effects 
can be treated. Some side effects may go away when you stop taking the study drug. Some side effects 
can be mild, but others may continue longer or become permanent. Some may be life-threatening or 
fatal.
As this study continues, the drug manufacturer may learn more information about the study drug. You 
will be given new information about this study in a timely manner. This way you can decide if you want 
to continue to take part in this study. You may be asked to read and sign a new consent form. 
Blood Draw Risks: The risks of a blood draw include pain, bruising, and the slight possibility of infection 
at the place where the needle goes in.  Some people feel dizzy or may faint during or after a blood draw.
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Group Risks:  Although your name will not be given to researchers, basic information such as your race, 
ethnic group, and sex may be shared. This information helps researchers learn whether the factors that 
lead to health problems are the same in different groups of people. It is possible that such findings could 
one day help people of the same race, ethnic group, or sex as you. However, they could also be used 
to support harmful stereotypes or discrimination.
Privacy Risks - Your name and other information that could directly identify you (such as an address, 
date of birth, or social security number) will never be placed into a database . However, because your 
genetic information is unique to you, there is a small chance that someone could trace it back to you. 
The risk of this happening is very small, but may grow in the future. Since the database contains 
genetic information, a break in security may also pose a potential risk to blood relatives as well as 
yourself. For example, it could be used to make it harder for you (or a relative) to get or keep a job or 
insurance. If your private information was misused, it is possible you would experience other harms, 
such as stress, anxiety, stigmatization, or embarrassment from revealing information about your 
family relationships, ethnic heritage, or health conditions.
Privacy risks always exist, but there are procedures in place to minimize the risk. 
As of 28 June 2021, 732 participants with vitiligo, a condition where the skin loses its pigment cells, 
have been treated with ruxolitinib 0.15%, 0.5%, or 1.5% cream once daily or twice daily.  Based on the 
information provided to date, the following are the most frequent side effects that have occurred:
Common 
Out of 100 people who use ruxolitinib cream, at least 2 but less than 10 people (2-10%) have reported 
the following:
•
General acne
•
Infections (including common cold, upper respiratory tract infection, COVID-19, sinus infection)
•
Headache
•
Itching at the site of Study Cream application
•
General itching
Also, the following side effect was reported in at least 1 but less than 2 out of 100 people (1-2%) who 
used ruxolitinib cream: Acne at the site of drug application
As of 28 June 2021, 203 participants with psoriasis have been treated with ruxolitinib 0.5%, 1.0%, or 
1.5% cream once daily or twice daily.  The following are the most frequent side effects that have 
occurred:
Common 
Out of 100 people who used ruxolitinib cream, at least 3 but less than 10 people (3-10%) have reported 
the following side effects:
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•
Infections (including common cold, upper respiratory tract infection, and sinus infection)
•
Application site skin reactions (including irritation and itching)
•
Headache
•
General itching
•
Potential heart beat abnormality (electrocardiogram QT interval abnormality)
As of 28 June 2021, 83 participants with alopecia areata have been treated with ruxolitinib 1.5% cream 
twice daily.  The following are the most frequent side effects that have occurred:
Very common
Out of 100 people who use ruxolitinib cream, 10 or more people (10%) have reported the following:
•
Common cold
•
General itching
Common
Out of 100 people who used ruxolitinib cream, at least 8 but less than 10 people (8-10%) have reported 
the following: 
•
Sinus infection
As of 28 June 2021, 1,595 participants with atopic dermatitis (eczema) have been treated with ruxolitinib 
0.15%, 0.5%, 0.75%, or 1.5% cream once daily or twice daily.  The following are the most frequent side 
effects that have occurred:
Common
Out of 100 people who use ruxolitinib cream, at least 2 but less than 10 people (2-10%) have reported 
the following:
•
Infections (including common cold, upper respiratory tract infection, bronchitis)
•
Headache
•
Eczema
•
Runny nose
Also, the following side effect was reported in at least 1 but less than 2 out of 100 people (1-2%) who 
used ruxolitinib cream: Burning or stinging sensation at the site of drug application
No rare but serious side effects occurred in participants with psoriasis, alopecia areata, atopic 
dermatitis, or vitiligo who were treated with ruxolitinib cream.
No side effects occurred during the use of ruxolitinib 1.5% cream in healthy participants that were very 
common, common, or rare but serious.
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Oral Ruxolitinib
While this Study will evaluate ruxolitinib as a cream, another form of ruxolitinib is taken by mouth and 
is known as “oral ruxolitinib.”  This oral ruxolitinib is approved for the treatment of adult patients with 
myelofibrosis (a disease of the fatty substance inside bone where blood cells are produced), 
polycythemia vera (a blood cancer wherein too many red cells are produced), and in the US for the 
treatment of adult and pediatric patients 12 years and older with graft versus-host disease (a 
complication that can develop after a person has had a bone marrow or stem cell transplant).  
In clinical studies with oral ruxolitinib,  the most common side effects seen in participants with 
myelofibrosis, polycythemia vera, or graft-versus-host disease were thrombocytopenia (low platelet 
count), anemia (low red blood cells), and neutropenia (low white blood cell count).  Changes in blood 
cell counts are believed to be related to increasing dose of the drug.  The most frequent side effects 
that were not directly related to the blood cells were bruising, dizziness, headache, increased liver 
enzymes, high cholesterol, constipation, and herpes zoster (shingles) infection.
When considering these side effects of ruxolitinib given by mouth, it is important to understand that the 
dose strengths that produced these side effects are much higher than for ruxolitinib cream.  Also, an 
oral dose of the drug results in much higher levels of ruxolitinib in the body than the amount that can be 
absorbed from applying ruxolitinib cream to the skin.  The amount of ruxolitinib cream absorbed in the 
body after application is about 90% lower than that of the oral ruxolitinib.  Therefore, the risk of theseside 
effects from topical use of the drug is anticipated to be very low.  So far, they have not been observed 
with ruxolitinib cream.
 If you are or become pregnant, this research may hurt your baby or your pregnancy in ways that are 
unknown. The unknown risks might be minor or might be major (death) for the pregnancy. You should 
not become pregnant or impregnate a woman while on this research study. Please read the acceptable 
methods of birth control found under the Description of What’s Involved section of this document.
OTHER OPTIONS TO CONSIDER:
You may decide not to take part in this research study. If you decide not to take part, this will not 
affect the clinical care you receive at Mount Sinai. The choice is totally up to you.
Instead of being in this research study, your choices may include: topical corticosteroids and antifungal 
creams. However, they have a maximum duration of use. Using corticosteroids over a long period of 
time may result in thinning of the skin. 
The study doctor will discuss other options and their potential risks and benefits with you before you 
decide whether you will take part in this study. You may also discuss your options with your regular 
doctor.
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IN CASE OF INJURY DURING THIS RESEARCH STUDY 
If you are injured or made sick from taking part in this study, you will get medical care. The group 
funding this research study will pay you for any reasonable and necessary medical expenses to 
diagnose and treat research-related injury or illness. This does not prevent you from seeking payment 
for injury related to malpractice or negligence. You can contact the Lead Researcher for more 
information.
The Centers for Medicare and Medicaid Services (CMS) is the government agency that oversees 
Medicare and Medicaid. Funding agencies who make payments for injuries related to studies must 
report payments to CMS. In order to do this, the funder must have certain information about you, such 
as your name, date of birth, Social Security Number, Medicare or Medicaid ID numbers, date of injury, 
and description of injury. The funding agency is only allowed to use this information to report 
payments related to the injury should this be necessary or as otherwise specified in the Authorization 
to Use and Disclose Protected Health Information section, which is included below.
____________________________
ENDING PARTICIPATION IN THE RESEARCH STUDY:
You may stop taking part in this study at any time.  No matter what you choose, your care and 
benefits through Mount Sinai will not be negatively impacted.
If you decide to stop being in the study, please contact the Lead Researcher or the research staff. For 
your safety, once you stop the study drug you will be asked to complete the End of Treatment Visit and 
Follow-Up Visit tests (as described in the description section of this form).
You may also withdraw your permission for the researchers to use and share any of your protected 
information for research, but you must do so in writing to the Lead Researcher at the address on the 
first page. Even if you withdraw your permission, the Lead Researcher may still use the information 
that was already collected if that information is necessary to complete the research study. Your health 
information may still be used or shared after you withdraw your authorization if you have an adverse 
event (a bad effect) from taking part in the research study.
If you decide to stop being in the research study, the following may occur: any improvements in your 
SD may be lost or your SD may worsen. 
If you stop being in the research study, the research team may not remove information they have 
already placed in the study database, and may continue to use that data as part of this study.  The 
research team may ask you whether they can continue to collect information from your medical 
record.  
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If you decide you don’t want your data and/or samples to be used for research anymore, you can 
contact the researcher and ask to have your data and/or samples withdrawn or labeled so that they 
will not to be used in additional projects or shared. If your data and/or samples have already been 
shared with researchers, those researchers will be asked to stop using them. However, if any data 
and/or samples have already been shared without your identity or a linking code, it won’t be possible 
to retrieve them. Data and/or samples that have already been used will not be affected by your 
decision. If your data and/or samples have already been deposited in an external repository, the study 
team will request that your data and/or samples be removed.
Withdrawal without your consent: The Lead Researcher, the funder or Mount Sinai may stop your 
involvement in this research study at any time without your consent. This may be because the 
research study is being stopped, the instructions of the research team have not been followed, the 
Lead Researcher believes it is in your best interest, or for any other reason. If data and/or samples 
have been stored as part of the research study, they too can be destroyed without your consent.  
____________________________
CONTACT INFORMATION:
If you have any questions, concerns or complaints at any time about this research, or you think the 
research has harmed you, please contact the office of the research team and/or the Lead Researcher 
at phone number 212-241-3288.
If there is an emergency, call 911 or go to the emergency room. Let the emergency room staff know 
you are in a research study so they can contact the Lead Researcher if needed. Once you are able to, 
please contact the study team.
____________________________
DISCLOSURE OF FINANCIAL INTERESTS:
Researchers sometimes get paid for consulting or doing work for companies that produce drugs, 
biologics or medical devices. If you have questions regarding industry relationships, you are 
encouraged to talk to the Lead Researcher or visit our website at http://icahn.mssm.edu/ where Mount 
Sinai publicly discloses the industry relationships of our faculty.   
The company sponsoring this research study, Incyte, makes the drug being tested and has a financial 
interest that could be affected by the outcome of this research study.
Incyte Corporation is the study sponsor and developer of the study drug, ruxolitinib.
Dr. Emma Guttman (a co-investigator in this study) receives financial compensation as a consultant 
for the study sponsor, Incyte Corporation. Dr. Guttman also receives financial compensation as a 
consultant for companies that research and develop treatments for dermatological diseases.
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If you have questions regarding paid relationships that your physician/researcher may have with 
industry, we encourage you to talk with him or her, or check for industry relationships posted on 
individual faculty pages on our website at http://icahn.mssm.edu/.
____________________________
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
As part of this study, some of your private and/or protected health information will be obtained, used, 
and shared with your permission. There is a Federal Health Insurance Portability and Accountability 
Act (HIPAA) that makes sure this is done correctly and safely. 
What is protected health information (PHI)? 
PHI is the combination of two things:
1.
PHI contains information that identifies you. It will be used to contact you and link you to your 
health information, like name, date of birth, medical record number, and address.  
2.
PHI also contains health information, including information about your mental and physical 
health from your visits to doctors or hospitals, or from study visits. 
Every time you visit a hospital or your doctor, PHI is created and recorded in your medical record by 
your healthcare providers. In the same way, the PHI created as part of this study will be linked to who 
you are and your medical information. 
What PHI is collected and used in this research study, and might also be shared with others? 
As part of this study, the research team at the hospital(s) involved in the research will collect your 
name, address, telephone/fax numbers, dates directly related to the individual (birth, admission, 
discharge, date of death, etc.), e-mail social security number, or photographic images 
During the study, the researchers will gather information by: 

Reviewing and/or taking your medical history (includes current and past medications or 
therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.) 

Doing a physical examination that generally also includes blood pressure reading, heart rate, 
breathing rate, and temperature.

Completing the tests, procedures, questionnaires and interviews explained in the description 
section of this consent.

Reviewing HIV-related information, which includes any information indicating that you have 
had an HIV-related test, or have HIV infection, HIV-related illness or AIDS, or any information 
which could indicate that you have been potentially exposed to HIV
Why is your PHI being used?
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Researchers need the information that identifies you so they can contact you during the study. They 
need your health information and the results of any tests and procedures being collected as part of 
this study to answer the questions posed in the study. The purpose of the study is discussed earlier in 
this consent form. Before researchers analyze the data, they remove any information that would let 
others know who you are or that you took part in the study. If researchers publish or present study 
results at scientific meetings, lectures, or other events, their presentations would not include any 
information that would let others know who you are, unless you give separate permission to do so.
The Lead Researcher may also use and share the results of these tests and procedures with other 
healthcare providers at Mount Sinai who are involved in your care or treatment. The research team 
and other authorized members of The Mount Sinai Health System (“Mount Sinai”) workforce may use 
and share your information to ensure that the research meets legal, institutional or accreditation 
requirements. For example:

The Mount Sinai Program for the Protection of Human Subjects is responsible for overseeing 
research on human participants and may need to see your information. 

If you receive any payments for taking part in this study, the Mount Sinai Finance Department 
may need your name, address, social security number, payment amount, and related 
information for tax reporting purposes.  

If the research team uncovers abuse, neglect, or reportable diseases, this information may be 
disclosed to appropriate authorities. 
Who, outside Mount Sinai, might receive your PHI?
As part of the study, the Lead Researcher, research team and others in the Mount Sinai workforce 
may disclose your PHI, including the results of the research study tests and procedures, to the 
following people or organizations: (It is possible that there may be changes to the list during this 
research study; you may request an up-to-date list at any time by contacting the Lead Researcher.)
-
The United States Department of Health and Human Services (DHHS) and the Office of 
Human Research Protection (OHRP) (the government organization that is responsible for 
protecting human research participants).
-
The commercial sponsor and/or their representative (who will use the results for 
submissions to the Food and Drug Administration (the government organization that 
approves drugs or devices for medical use): Incyte Corporation
-
The United States Food and Drug Administration.
 In all disclosures outside of Mount Sinai, you will not be identified by name, social security number, 
address, telephone number, or any other direct personal identifier unless disclosure of the direct 
identifier is required by law. Some records and information disclosed may be identified with a unique 
code number. The Lead Researcher will ensure that the key to the code will be kept in a locked file, or 
will be securely stored electronically. The code will not be used to link the information back to you 
without your permission, unless the law requires it, or rarely if the Institutional Review Board (IRB) 
allows it after determining that there would be minimal risk to your privacy. It is possible that a sponsor 
or their representatives, a data coordinating office, a contract research organization, may come to 
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inspect your records. Even if those records are identifiable when inspected, the information leaving 
the institution will be stripped of direct identifiers.  Additionally, when applicable, the monitors, 
auditors, the IRB, OHRP, as well as the Food and Drug Administration (FDA) will be granted direct 
access to your medical records for verification of the research procedures and data. OHRP and FDA 
are authorized to remove information with identifiers if necessary to complete their task. By signing 
this document you are authorizing this access. The results of this research may be published. 
However, your name and other identifying information will be kept confidential.
For how long will Mount Sinai be able to use or disclose your PHI? 
Your authorization for use of your PHI for this specific study does not expire.
Will you be able to access your records?
During your participation in this study, you will not be able to access your medical records. This is 
done to prevent the knowledge of study results from affecting the reliability of the study. Your 
information will be available should an emergency arise that would require your treating physician to 
know this information to best treat you. You will have access to your medical record and any study 
information that is part of that record when the study is over or earlier, if possible. The research team 
is not required to release research information to you that is not part of your medical record.
Do you need to give the researchers permission to obtain, use or share your PHI?
NO! If you decide not to let the research team obtain, use or share your PHI, you should not sign this 
form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not affect 
your treatment, payment, or enrollment in any health plans or affect your eligibility for benefits.
Can you change your mind?
If you decide to stop being in the study, please contact the Lead Researcher or the research staff.
The research team may ask you whether they can continue to collect information from your medical 
record. You will also have to decide if you wish to limit the continued use of the information collected 
during the study. Under US privacy laws you may also withdraw your permission for the researchers 
to use and share any of your protected information for research, but you must do so in writing to the 
Lead Researcher at the address on the first page. 
Even if you withdraw your permission, the Lead Researcher may still use the information that was 
already collected, but only to complete this research study. Your health information may still be used 
or shared after you withdraw your authorization if you have an adverse event (a bad effect) from 
taking part in the research study.
If you have not already received it, you will also be given The Hospital’s Notice of Privacy Practices 
that contains more information about how The Hospital uses and discloses your PHI.
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End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 20 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
It is important for you to understand that once information is disclosed to others outside Mount Sinai, 
the information may be re-disclosed and will no longer be covered by the federal privacy protection 
regulations. However, where possible, Mount Sinai has entered into agreements with those who will 
receive your information to continue to protect your confidentiality.
If researchers are reviewing your medical records or asking questions about your medical history or 
conditions, it is possible that they may learn information related to your HIV status. If that is the case, 
the following information concerns you. If researchers are not reviewing your medical records or 
asking questions about your medical history or conditions, then you may ignore the following section.
_________________________________________________________________________________
Notice Concerning HIV-Related Information 
If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is 
(are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted 
to do so under federal or state law. You also have a right to request a list of people who may receive or 
use your HIV-related information without authorization. If you experience discrimination because of the 
release or disclosure of HIV-related information, you may contact the New York State Division of Human 
Rights at (888) 392-3644 or the New York City Commission on Human Rights at (212) 416-0197. These 
agencies are responsible for protecting your rights.
_____________________________________________________________________________________
____________________________
How the Institutional Review Board (IRB) can help you:
This research has been reviewed and approved by an Institutional Review Board (IRB). You may 
reach a representative of the Mount Sinai Program for Protection of Human Subjects at telephone 
number (212) 824-8200 during regular work hours (Monday-Friday, 9am-5pm, excluding holidays) for 
any of the reasons listed below. This office will direct your call to the right person within the Mount 
Sinai Health System:

Your questions, concerns, or complaints are not being answered by the research team.

You cannot reach the research team.

You are not comfortable talking to the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
Effective Date: 7/28/2023
End Date:7/24/2024


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Page 21 of 21
Study ID: STUDY-22-00546                   
Form Version Date: 06 July 2023
----------------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------------------
Rev 11.11.2022 (Amendment 1-03.09.2023)
ADULT PARTICIPANT:
Your signature below documents your permission to take part in this research study and to the use 
and disclosure of your protected health information. A signed and dated copy will be given to you.
_________________________
_________________________
__________
__________
Signature of Participant
Printed Name of Participant
Date
Time
PERSON EXPLAINING STUDY AND OBTAINING CONSENT:
_________________________
_________________________
__________
__________
Signature of Consent Delegate
Printed Name of Consent Delegate
Date
Time
WITNESS SECTION:  N/A
My signature below documents that the information in the consent document and any other written 
information was accurately explained to, and apparently understood by, the participant, and that 
consent was freely given by the participant.
_________________________
_________________________
__________
__________
Signature of Witness
Printed Name of Witness
Date
Time
Effective Date: 7/28/2023
End Date:7/24/2024