Clinical trial NCT05293717
Conditions: Chronic Hand Dermatitis
Sponsor: University of Rochester
Start date: 2022-07-11; Completion date: 2024-12-31
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an investigator-initiated, proof of concept, open study to assess efficacy of a topical Ruxolitinib in subjects with Chronic Hand Dermatitis (CHD). The study will be conducted at the University of Rochester Medical center, Dermatology Department - Rochester, NY. Qualified and enrolled subjects (see Inclusion/Exclusion criteria) will be required to come to URMC Dermatology Clinic for at least five visits.

Detailed description:
This is a single-center study anticipating to enroll 15 participants with chronic hand dermatitis. Eligible participants will receive Ruxolitinib to apply twice daily for 12 weeks. Participants will be required to be seen every 4 weeks until week 16.

Arms: arm 1: You are being asked to apply topical medication called Ruxolitinib cream to your skin at home twice daily.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: 1.5% Ruxolitinib cream

Protocol documents:
Prot_SAP_000.pdf: 
De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
10/12/2023 
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NCT05293717 
 
CLINICAL STUDY PROTOCOL 
 
 
1. PROTOCOL SUMMARY 
Title: Topical Ruxolitinib (Jak1/Jak2 inhibitor) in Chronic Hand Dermatitis attenuates 
inflammation and enhances skin barrier repair.  
Principal Investigator: Anna De Benedetto, MD; 
anna_debenedetto@urmc.rochester.edu 
 
Single site: Department of Dermatology - University of Rochester Medical Center, 
Rochester, NY 
 
Study phase: Open label, proof of concept study 
 
Population: Females and Male, age 18 - 75 years, who have moderate to severe Chronic 
Hand Dermatitis (CHD) 
 
Number of participants: Up to 25 will be enrolled with 15 completing full study term 
 
Intervention:  Ruxolitinib cream 1.5% is an investigational drug that will be applied twice 
daily (BID) for 12 weeks (IND exempt) by the study participant. Ruxolitinib (Other Name: 
INCB018424) cream is a topical formulation applied as a thin film to affected areas.   
 
Objectives and Endpoints: 
Primary objective & outcome:  
1. To assess the efficacy of Ruxolitinib cream 1.5% on skin lesions in patients with 
Chronic Hand Dermatitis:     
- proportion of patients achieving an Investigators Global Assessment (IGA) score 
of 0 or 1 with at least a 2-step improvement (IGA treatment success) at week 12 
Hand Eczema Severity Index (HECSI)i-75% from baseline to week 12 
 
Secondary objective & outcome:  
- 
To assess the efficacy of Ruxolitinib cream 1.5% on other clinical domains: 
Time to IGA treatment success 
- 
Change in HECSI score from baseline to week 4, 8 and 12. 
- 
Proportion of subjects with a ≥ 2 and ≥ 4-point improvement in Itch 
Numerical Rating Scale (NRS) score from baseline to week 12.   
- 
HECSI-75% at week 8  
- 
HECSI-90% at week 12 
 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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2. To assess safety and tolerability of Ruxolitinib cream 1.5% in patients with chronic hand 
dermatitis: 
- 
incidence, frequency and severity of adverse events and laboratory data for 
hematology, serum chemistry and urinalysis 
- 
use of rescue medications 
 
 
 
Exploratory objective & outcome: 
1. To assess the effect of Ruxolitinib cream 1.5% on patient reported outcomes 
- 
Change from baseline to week 4, 8 and 12 in DLQI 
- 
Change from baseline to week 4, 8 and 12 in work productivity and activity 
impairment index 
 
2. To assess the efficacy of Ruxolitinib cream 1.5% on skin barrier integrity in patients 
with Chronic Hand Dermatitis:   
- 
change in transepidermal water loss (TEWL) and barrier integrity score 
(TEWL recovery after tape stripping) and pH from baseline to week 4 and 
end of treatment on perilesion (normal appearing) skin 
3. To identify translational skin biomarkers  
- 
change in the expression of selected biomarkers in skin samples obtained 
from tape stripping (d-squame) at baseline and end of treatment (week 12) 
- 
change in microbiome at baseline and end of treatment (week 12) 
 
Treatment groups and Duration: 
Will enroll up to 25 subjects with CHD; investigational drug will be applied twice a day for 
12 weeks by the subjects. Subjects will be asked to come back for a safety follow up visit 
every 4 weeks until end of treatment.  
 
2. STUDY RATIONAL  
Background: Chronic hand dermatitis (also known as hand eczema; CHD) is one of the 
most disabling skin conditions that negatively affect quality of life and work capacity of 
affected patients. Hands and often wrists present with erythema, edema, scaling and 
fissuring accompanied by intense pruritus and pain. Thyssen JP et al, reported the point 
prevalence of hand dermatitis (1994-2007) was around 4%, the 1-year prevalence nearly 
10%, whereas the lifetime prevalence reached 15%. A high incidence rate is associated 
with female gender, contact allergy, atopic dermatitis, and wet work environment.ii Hand 
dermatitis is a heterogeneous disease entity, with irritant and allergic contact dermatitis 
and atopic dermatitis (AD) as the main causative factors. The common denominator of 
CHD subtypes is a skin barrier dysfunction, which not only facilitates cutaneous 
penetration of allergens and irritants but also induces local immune activation.  Currently, 
the management of CHD involves patient education about avoidance of irritants and 
allergens, skin protection measures, and topical (high and mid potency steroids, 
calcineurin inhibitors) or systemic anti-inflammatory therapy (e.g. corticosteroids, 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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alitretinoin, cyclosporine, methotrexate, azathioprine). Overall the rate of treatment 
success is poor with great dissatisfaction from patients and providers. While previous 
approaches to CHD have been focused on broad spectrum suppression of immune 
responses, we are interested in a targeted approach to restore proper skin barrier integrity 
and resistance to absorption of environmental allergens/hapten/irritant while also blocking 
the cytokine mediated inflammation.   
It is our hypothesis that daily application of a topical JAK1/JAK2 inhibitor 
(Ruxolitinib) will induce clinical improvement of CHD by restoring skin barrier 
function and reducing skin driven inflammation. 
 
Preliminary study: The epidermal skin barrier is composed of the stratum corneum (SC), 
which is made up of terminally differentiated keratinocytes surrounded by a complex lipid 
structure and the tight junctions (TJs), which are present just below the SC. TJs are made 
up of a number of adhesive and scaffolding proteins that control the passage of 
physiologic liquids, water, ions, and solutes through the paracellular pathway. Expression 
of key barrier proteins (e.g. claudin-1, loricrin, filaggrin and cytokeratin 10) was found to 
be reduced in biopsies from CHD patients. Notably, in patients treated with oral alitretinoin 
the improved expression of these markers correlated with clinical efficacy, suggesting that 
alitretinoin exhibits a disease‐modifying activity by skin barrier repair mechanismiii.   
Janus kinase (JAK) inhibitors block cytokine-mediated signaling via the Janus kinase-
signal transducer and activator of transcription (JAK-STAT) pathway, which plays an 
important role in immunoregulation and cell growth.  Furthermore, recent studies have 
shown a critical role played by JAK1 signaling in sensory neurons driven chronic itchiv. 
JAK-STATs are heavily expressed in the epidermis and involved in critical epidermal 
barrier pathways.  Studies on epithelial model have shown that JAKs play a role in TJ 
protein expressionv. Consistently, preliminary data generated in our laboratory showed 
that Ruxolitinib was able to rescue IFNɣ-induced TJ disruption (Fig 1).  
 
Design & Methodology. This is an investigator-initiated, proof of concept, open study to 
assess efficacy of a topical Ruxolitinib in subjects with CHD.  The study will be conducted 
at the University of Rochester Medical center, Dermatology Department – Rochester, NY. 
Fig 1. In Primary human keratinocytes IFNɣ reduced TransEpithelial Electric resistance (TEER) and this was 
associated to disruption of TJ - Ruxolitinib (Rux) rescued IFNɣ induced TJ damage. A) TransEpithelial Electric 
resistance measures TJ integrity: reduced TEER  
reduced barrier integrity. B-D) Keratinocytes were stained with ZO-1 (TJ markers) 120hr post differentiation.  
2 4 h r
4 8 h r
7 2 h r
9 6 h r
1 2 0 h r
0
5 0 0
1 0 0 0
1 5 0 0
2 0 0 0
O h m s  x  c m 2
R u xo litin ib
IF N g a m m a
R ux/IF N
* *
D iff O n ly
A
B
C
Control
IFNɣ


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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Qualified and enrolled subjects (see Inclusion/exclusion criteria) will be required to come 
to URMC Dermatology Clinic for at least five visits: visit 1 (V1, day 0), start of active 
treatment; visit 2 - 4 weeks treatment; visit 3 – 8 weeks and visit 4 – 12 weeks and end 
of the active study; visit 5 post treatment follow uo, 4 weeks (V5, 112+/- 3 days post V1). 
To ensure feasibility of enrollment, and in subjects requiring a washout period, we will 
include a screening visit (up to 28 days +/- 3 prior to V1).  As part of the screening, 
subjects with possible contact allergy dermatitis (CAD) will undergo PATCH testing (70 
common allergens, North America series; see exclusion criteria) or they must have 
documentation of test performed 3 years prior screening. In patient with CHD avoidance 
of the allergens should be the first measure to ensure successful treatment. Subjects with 
known antigen sensitization based on Patch test (with 3 years) that are unable to reduce 
contact with the specific antigen(s) will be excluded.   
We will also exclude patients with active lesions of Atopic Dermatitis and Psoriasis (see 
exclusion criteria), as they might need additional systemic or topical treatment that could 
indirectly affect hand dermatitis severity during the study. 
Subjects will apply topical Ruxolitinib 1.5% cream twice a day for 12 weeks on 
eczematous areas of hands and adjoining clinically normal (perilesional) area. We 
included non-lesional/perilesional skin to evaluate the safety (e.g. irritant or toxic effects) 
of the compound on irritated/atopic skin, as those subjects have a lower irritancy 
thresholdvi. Also, skin barrier impairment (e.g. increase water loss/TEWL) can be already 
detected in normal appearing skin in atopic subjects and it is thought to allow penetration 
of hapten/allergen/irritant with consequent activation of an inflammatory response. It is 
our hypothesis that treatment with topical Ruxolitinib, a JAK1/JAK2 inhibitor, will 
normalize skin barrier integrity in perilesion skin. During the study, subjects will be allowed 
to stay on bland moisturizer and anti-histamine on a stabilized dose and expected to 
maintain this dose throughout the study.  In addition to clinical and safety outcomes, 
the study design will include exploratory mechanistic outcomes, in a stepwise tactic. 
During the trial we will collect: 1) non-invasive skin barrier assessment (i.e. TEWL, SC 
integrity score); 2) stratum corneum extract to investigate potential biomarkers and skin 
microbiome (stored for future investigation); 3) Patient oriented outcomes. If the data 
gathered from the clinical trial demonstrates the clinical improvement we expect, the 
mechanistic studies will be extremely relevant to start clarifying specific target 
downstream to Ruxolitinib efficacy in CHD as well as biomarkers that could eventually be 
investigated in consequent larger clinical trials. 
 
ADMINISTRATIVE ORGANIZATION  
UR Dermatology at College Town is the only participating site in this research study. 
 
3. STUDY POPULATION 
Number of patients: Up to 25 total subjects. We might need to enroll additional subjects 
in case of subject early discontinuation to reach the total number of 15 evaluable subjects 
(complete data set). 
 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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Study population: Females and Male, age 18-75 years, who have Chronic Hand 
Dermatitis  
Racial and Ethnic Origin: We will not have any restrictions based on racial or ethnic 
origin. We based our target research population racial and ethnic distribution on the data 
of the 2000 United States Census for the Monroe County Area.  
Vulnerable subjects: We will not be targeting vulnerable subjects 
 
Inclusion Criteria: 
• 
Age 18-75 years. 
• 
Diagnosis of chronic hand eczema defined as hand eczema, which has persisted 
for more than 3 months or returned twice or more within the last 12 months. 
• 
Disease severity graded as moderate to severe according to IGA (i.e., IGA ≥2). 
• 
Recent history (within 1 year before the screening visit) of inadequate response to 
topical 
corticosteroid 
and/or 
calcineurin 
inhibitors treatment 
or 
topical 
corticosteroid treatment being medically inadvisable. 
 
Exclusion Criteria: 
• 
Active atopic dermatitis in regions other than the hands requiring medical 
treatment. 
• 
Active psoriasis in regions other than the hands requiring medical treatment. 
• 
Clinically significant infection (e.g., impetiginized hand eczema or tinea manuum) 
on the hands. 
• 
Patients with excessive contact of hands with water (longer than 2 hours a day; or 
> 20 hands washing at day) that is believed to be a predominant cause of the hand 
dermatitis. 
• 
Subjects with known antigen sensitization based on Patch test (with 3 years) that 
are unable to reduce contact with the specific antigen(s). 
• 
Subjects chronically and consistently exposed to known irritant or other substance 
known to impact skin barrier will be excluded based on PI judgement. 
• 
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, 
retinoids, or corticosteroids within 4 weeks prior to baseline. 
• 
Systemic treatment with antibiotics within 4 weeks prior to baseline 
• 
Phototherapy on the hands within 4 weeks prior to baseline. 
• 
Use of topical immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, 
pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks 
prior to baseline. 
• 
Use of topical antibiotics on the hands within 2 weeks prior to baseline. 
• 
Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., 
subjects must not start antihistamine treatment or change the current dosage 
regimen within 2 weeks prior to baseline. 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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• 
Other topicals applied therapy on the hands (except for the use of subject's own 
emollients) within 1 week prior to baseline. 
• 
Receipt of any marketed or investigational biologic agents within 6 months or 5 
half-lives prior to baseline will be in the judgement of the investigator whether or 
not study drug may affect or interact with study drug’s mechanism of action. 
• 
Any disorder which is not stable and in the investigator's opinion could affect the 
safety of the subject, influence the findings of the trial, or impede the subject's 
ability to complete the trial. 
• 
Participants with clinically significant cytopenia at screening. 
• 
Participants with severely impaired liver or kidney function and unstable. 
• 
Participants who have previously received JAK inhibitor therapy, systemic or 
topical. 
• 
History of any known primary immunodeficiency disorder including a positive 
human immunodeficiency virus (HIV), or the subject taking antiretroviral 
medications. 
• 
Females who are breastfeeding, pregnant, or anticipate becoming pregnant during 
the study time frame.  
• 
History of skin cancer on hands within 5 years. 
• 
History of recalcitrant warts on hands within 1 year. 
 
4. STUDY TREATMENT & DESIGN 
Study design: This is an open label, proof of concept single site study and will be 
conducted at the Department of Dermatology, URMC 
- Screening visit (-28 days before start of treatment) 
- visit 1 - (V1, day 0), start of active treatment;  
- visit 2 – 28 +/- 3 days (4 weeks) treatment;  
- visit 3 – 56 +/- 3 days (8 weeks) treatment; 
- visit 4 – 84 +/- 3 days (12 weeks) end of treatment 
- visit 5 – 112 +/- 3 days (16 weeks) safety follow up 4 weeks post treatment 
- during each visit a skin swab will be collected and stored in the lab for future microbiology 
study 
-Skin Symptom questionnaire will be done during each visit.  
 
Screening visit (-28 days) 
 
1) Consenting and confirmation of inclusion & exclusion criteria 
2) Medical history  
3) Physical exam with focus on skin exam  
4) Collection of concomitant medications 
5) Fasting blood draw for safety labs (CBC with diff, Chemistry, Lipid panel)  
6) Urinalysis  
7) Possible washout period  


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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8) Possible schedule PATCH test if investigator believes clinically necessary to r/o 
contact dermatitis 
9) Urine Pregnancy test for woman of childbearing potential 
10) Scheduling visit 1 
 
Visit 1 (Day 0):  
 
1) Confirmation of inclusion & exclusion criteria 
2) General history 
3) Physical exam  
4) Review of concomitant medications  
5) Urine pregnancy test for woman of childbearing potential at each visit. Counseling 
on acceptable birth control measures to use throughout treatment period including 
30 days after stopping study drug (16 weeks or 112 days) 
6) Clinical scores for chronic hand dermatitis 
7) Itch and other QoL assessments; review daily diary 
8) Digital pictures of the target area/hands 
9) Non-invasive skin barrier Measurements: TransEpidermal Water Loss (TEWL) and 
optional pH may also be performed 
10) Repeated tape stripping (Cuderm™ tape) of peri-lesional (0, 5, 10, 15, 20 tape) 
locations from treated area will be collected as part of the TEWL assessment and 
to assess for SC cohesion/integrity (rate of change in TEWL with repeated 
stripping). Serial measurements of TEWL will be performed after tape stripping as 
previously describedvii. This will also allow collecting proteins (eluded from the 
tape) for validation of biomarkers 
11) Dispense Investigational drug for 4 weeks  
12) Provide instructions to complete at home diary.   
13) Provide date of Visit 2 
14) Weight of the tube to check for subject’s compliance  
15) Skin swabs (optional) 
16) Skin symptom questionnaire (optional) 
 
Visit 2 (Day 28 +/-3) and Visit 3 (Day 56 +/-3) and Visit 4 (Day 84 +/-3): 
 
1) Review subject diary and address any questions, concerns, or missed doses 
2) Review of concomitant medications  
3) Adverse events assessment  
4) Questionnaire to clinically characterize CHD  
5) Urine Pregnancy test for woman of childbearing potential. 
6) Clinical score for CHD  
7) Itch and other QoL assessments, review daily diary 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
10/12/2023 
8 
 
8) Digital pictures of the targeted area 
9) Non-invasive skin barrier Measurements: transepidermal water loss. Optional: pH  
10) Repeated tape stripping (Cuderm™ tape)  
11) Dispense investigational drug for following 4 weeks (except Visit 4, end of 
treatment) 
12) Review Diary instructions 
13) Weight of the tube to check for subject’s compliance  
14) Provide date for next visit  
15) Skin swabs (optional) 
16) Skin symptom questionnaire (optional) 
 
Visit 5 (Day 112 +/-3):  
1) Review subject diary and address any questions, concerns, or missed doses 
2) Review concomitant medications  
3) Adverse Events Assessment  
4) Questionnaire to clinically characterize CHD  
5) Urine Pregnancy test for woman of childbearing potential. 
6) Clinical score for CHD  
7) Itch and other QoL assessments; review daily diary 
8) Digital pictures of the targeted area 
9) Non-invasive skin barrier Measurements: transepidermal water loss.    Optional: 
pH and skin swab 
10) Repeated tape stripping (Cuderm™ tape)  
11) Weigh returned tubes 
 
Unscheduled Visit(s) 
Any follow-up assessment that is performed to monitor a subject will be collected as an 
unscheduled visit.  The study team is responsible for review of any side effects, 
concomitant medications, and a brief physical examination. The remaining elements of 
the unscheduled visit are up to the discretion of the investigator and may include any of 
the events listed in Visits 1 through Visit 5.  
 
Study procedures & methods 
- 
Disease status assessment: 1) Investigator Global Assessment (IGA), which will 
provide information of the overall disease (5-point scale: clear, almost clear, mild, 
moderate, severe) and it is the score requested by FDA for clinical study. Data will 
be reported as and 2) Hand Eczema Severity Index (HECSI)viii, a well-accepted and 
validated scoring system for disease activity. It incorporates both the extent and the 
intensity of the disease. Each hand is divided into five areas: fingertips, fingers 
(except the tips), palms, back of hands and wrists. Each area will be score for 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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extension and intensity of the six following clinical signs: erythema, 
induration/papulation, vesicles, fissuring, scaling and edema; which are graded on 
the following scale: 0, no skin changes; 1, mild disease; 2, moderate and 3, severe 
(see appendix). Data will be reported as percent change in HECSI score from 
baseline to week 4, 8 and 12.  
The presence or absence of skin irritation (e.g. macular/papular eruption), redness, 
atrophy and telangiectasia will be noted at each study visit.  
- 
The pruritus intensity will be assessed using Itch Numerical Rating Scale (NRS; 
see appendix). Data will be reported as proportion of participants with a ≥ 2 and 4-
point improvement in Itch Numerical Rating Scale (NRS) score from baseline to 
week 4, 8 and 12.  The NRS comprised of one item and represents the numbers 0 
(“no itch”) to 10 (“worst imaginable itch”). Subjects are asked to rate the intensity of 
their itch using this scale. The Dermatology Life Quality Index (DLQI) measured 
6 disease-specific domains (symptoms and feelings, leisure, daily activities, work 
and school, personal relationships, and treatment) during the last week; individual 
items were summed to generate an overall score. Data will be reported as change 
from baseline to week 12 in DLQI. The Work Productivity and Activity 
Impairment-Chronic Hand Dermatitis (WPAI-CHD) questionnaire elicited the 
number of work hours missed, hours worked, and impairment while 
working/performing usual daily activities as a result of chronic hand dermatitis 
during the past 7 days. The sum of work time missed and work impairment while 
working yielded the overall work impairment measure. All scores were expressed 
as percentages, with higher scores indicating greater impairmentix. Data will be 
reported as change from baseline to week 12 in work productivity and activity 
impairment index. Will also collect Skin Symptom Questionnaire routinely used by 
the URMC dermatology department 
- 
Digital pictures: A digital picture will be taken with a dedicated digital camera using 
the Haiku App. The pictures will be labeled with the subject’s study ID and date. 
Pictures will not include identifying information (e.g. facial features, tattoo, etc). 
Pictures will be taken at a distance for easy identification of the anatomical area 
and closer to better capture clinical changes. Digital photographs will be used to 
record the location and monitor the size of target lesions.   
- 
Venous blood sample: blood will be obtained for safety lab  
- 
Skin barrier measurements: Transepidermal water loss/TEWL, +/- pH will be 
obtained on treatment area at a perilesional site.  This measurement asses the 
dryness and health of the skin. For each of the specific measurements, a probe will 
be gently applied on the skin surface for up to 1 minute. We will perform all 
measurements in a climate-controlled examination room with consistent 
temperature (~23℃) and humidity (~50%).  The patient must be very comfortable 
in the room in which they are being tested to ensure that perspiration due to stress 


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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or acclimatization does not alter the TEWL. TEWL will be assessed using a non-
invasive skin probe that measures skin hydration - or other similar device available 
in the CTU. The URMC department of Dermatology owns the devices and has 
experience with measurements. Stratum Corneum (SC) integrity: the most 
superficial layers of the skin will be collected by tape stripping using D-squame (D-
squame®, CuDerm, Dallas TX, USA). This is a well-established method used in 
clinical research to gently perturb the skin barrier. The first tape will be discarded to 
eliminate dirt and remnants of skin products. Each tape will be gently pressed 
against the skin with standardized pressure for 5-10 seconds (sec) using a 
standardized pressurizer (D500–D-squame® pressure instrument, CuDerm)).  All 
subjects will have 20consecutive tapes collected from lesional skin as part of this 
study. TEWL will be measured after each set of 5 tape strippings. These 
measurements should provide data to determine if the treatment has an effect on 
skin barrier integrity. Dsquame tapes will be collected and stored in -80 C freezer 
(see below).  Expression of relevant biomarkers can be investigated using RNA or 
protein eluted from the tapes. Dr. De Benedetto’s lab is familiar with the methods 
and analysis 
- 
Skin swab: will be collected at each visit. Briefly a sterile swab will be rolled on the 
dorsal hand (non-dominant hand) at each visit and stored at -80C for future analysis 
- 
Study Drug Diary: subjects will be provided with a prepopulated dated calendar to 
record their twice daily (AM and PM) application of study medication as well as the 
time the medication is applied.  Also, on this diary the subject can indicate if a 
missed dose occurred and there is a blank space they can write in the reason it was 
missed.  At the END of each day the subject will need to indicate on the same study 
diary their level of hand dermatitis itch throughout the day – 0=no itch and 10=worst 
imaginable itch. Subjects will indicate their level 0-10 by circling the number that 
best applies to them for that particular date.  Detailed instructions are provided on 
the Incyte Study Diary as well as contact information of coordinator.  
 
Prohibited 
Medications 
and 
procedures: 
use 
of 
topical 
or 
systemic 
immunosuppression/immunomodulators medications and Phototherapy is not permitted 
during the study. Hand surgery or other procedures (including but not limited to 
Cryotherapy, ED&C, skin biopsy) are disallowed during the study. If medically necessary, 
the investigator will withdraw the patients from the study. 
 
5. RISK, BENEFITS and PROTECTION AGAINST RISKS 
Risks Associated with Digital Picture 
There are no known risks for the digital picture. The image will not include identifying 
features and will be labeled with study subject ID and date. Pictures will be taken with a 
dedicated camera, stored on a secure server. Pictures will be taken through the Haiku 
App and stored in the patients EMR in Epic.  


De Benedetto 
Protocol V1. 10-22-2019, V2. 11/01/2021, V3. 03/07/2022, V4. 06/21/2022, V5 07/11/2022, V6 09/30/2022, V7 10/13/2022, V8 1/5/2023, V9 
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11 
 
 
Risks Associated with Barrier Assessments 
There are no known risks for the barrier assessments. 
 
Risks Associated with Tape Stripping 
The risks associated with tape stripping, theoretically, include the rare possibility of an 
allergic reaction to the tape and infection.  Since the tape is removed immediately after 
application, the risk of reaction is extremely low.  In previous and ongoing studies 
involving tape stripping, it has been noted that a very mild erythema may develop 
immediately after a series of tape strippings on one localized area of skin, presumably 
due to the mild mechanical disturbance.  The erythema is expected to resolve within 12 
hours without sequelae.  The risk of skin infection is extremely low since only superficial 
skin layers are removed.  Subjects will be provided with wound care information and a 
department phone number to contact should they have any concerns.  
 
Risks of Phlebotomy 
The risks of having blood drawn include some pain when the needle goes in, and a 
small risk of bruising and/or infection at that site. Some people will get lightheaded, 
nauseous, or faint. Approximately 3 teaspoons of blood will be drawn and is not likely to 
cause lightheadedness, however subjects will be observed after blood draw to be sure 
they are comfortable with ambulation.  Subjects will be encouraged to drink plenty of 
water prior to the blood draw. Phlebotomy will be performed at the antecubital fossa to 
minimize pain and bruising. Subjects will be seated during the blood draw to minimize 
dizziness and any risk of falling. Pressure will be applied to the site after the draw and a 
band-aid will be applied to minimize the risk of bleeding and infection.  Fasting 
laboratories will be processed at URMC local lab. We require fasting laboratories as the 
lipid panel can be influenced by food intake and it is routine care to do fasting 
laboratories of at least 6 hours.  Due to known side effects of systemic class of 
medication we want to screen patients for leucopenia, high lipids, liver or kidney 
diseases; normal or non-clinical significant labs at baseline are useful to rule out these 
problems and can be helpful in case we have side effects during the study. 
The clinical trial team will receive and review the laboratory results between 24-48 
hours.  
 
 
 
Risks of Ruxolitinib 1.5% cream 
Skin-related side effects of ruxolitinib cream are rare, but have included local irritation, 
pain, itch, redness, acne, and rash. While other side effects are not expected and have 
not been seen in other studies of ruxolitinib cream, there is a potential risk of side effects 


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12 
 
that have been observed with much higher doses of ruxolitinib when given by mouth. 
These risks include infection, low blood counts, liver inflammation, elevated cholesterol, 
dizziness, headache, fatigue, insomnia, diarrhea, and abdominal pain. As with any 
treatment, there is a small risk of an allergic reaction, though this has not been 
documented for ruxolitinib cream.  
There is a risk of no change or worsening of disease, as would be true with any change 
in treatment.  
 FDA approved medication label information, risks include:  
• Patients treated with oral JAK inhibitors for inflammatory conditions are at risk for 
developing serious infections that may lead to hospitalization or death 
• Reported infections include: 
o Active tuberculosis (TB), which may present with pulmonary or 
extrapulmonary disease 
o Invasive fungal infections (eg, candidiasis, pneumocystosis) 
o Bacterial, viral, and other infections due to opportunistic pathogens 
• Avoid use in patients with an active, serious infection, including localized infections 
• If a serious infection develops, interrupt therapy until infection is controlled 
• Do not resume until the infection is controlled. 
• Carefully consider the risks and benefits of treatment before initiating therapy in 
patients with chronic or recurrent infection 
• Closely monitor for developing signs and symptoms of infection during and after 
treatment 
 
Reproductive Risks 
Women of childbearing potential will be counseled to use acceptable birth control 
methods. Women will not be allowed to participate in this study if they are pregnant, 
become pregnant, or are nursing an infant. 
 
General Risks 
When participating in any research study there is a possibility for invasion of privacy or 
breach of confidentiality. As with any research study, there may be additional risks that 
are unknown or unexpected.  The subjects are advised to contact their study team with 
any questions and/or concerns. At that time the study team will determine whether or 
not any untoward medical occurrence is associated with the study and/or study drug 
and will be recorded on the Medical History and/or Adverse Event page of the source 
document. 
 
Adverse Event Reporting 
An adverse event (AE) is any observation whether or not considered to be product 
related, that is unfavorable and unintended and that occurs after any use of an 
investigational medicinal product. 


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Any observation of abnormality will be documented on the Adverse event form.  The 
Investigator will document the date of occurrence, severity, resolution, and will assess the 
relationship of the adverse event to the study drug by assigning a causality assessment. 
Results from laboratory evaluations which are outside of the laboratory reference range 
will constitute an adverse event only if the Investigator determines that the result is 
clinically significant.  
Severity will be assessed by the following system:  
• 
Mild: easily tolerated, causing minimal discomfort  
• 
Moderate: sufficiently discomforting to interfere with every day activities  
• 
Severe: prevents normal every day activities 
Serious Adverse Events (SAE) 
FDA definition: A serious adverse event results in death, is life-threatening, requires 
inpatient hospitalization or prolongation of existing hospitalization, results in persistent 
or significant disability / incapacity, results in a congenital anomaly / birth defect. Events 
fitting these descriptions will be considered adverse events if they occur after treatment 
with the study drug. 
As soon as reasonably possible, subjects will contact the Investigator to report any 
unfavorable events. The Investigator will assess the case, determine the need for 
treatment, and consult with Incyte, Inc, particularly in the occurrence of: 
• 
A serious adverse event. 
• 
An unusual frequency of non-serious adverse events. 
• 
Death, even if this does not appear to be related to therapy with the study 
drug.  
The Investigator will notify the URMC Institutional Review Board within approximately 3 
working days if a serious adverse event occurs.  
 
SAE Reporting to Incyte 
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 30 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. 


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14 
 
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 that 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. 
Causality assessments 
Probable 
              All of the following apply: 
• 
Reasonable association in time between the administration of the study drug 
and onset and duration of the reported event. 
• 
Description of the clinical phenomenon should be consistent with, or at least 
plausible, given the known pharmacology and toxicology of the product. 
• 
There should be no other equally plausible explanation(s) of the case. In 
particular, concurrent use of other products (and possible interactions) or 
concurrent disease should be taken into account in the assessment. 
Possible 
• 
The causality is one (of other) possible and plausible causes for the described 
event, but the data do not meet the criteria for inclusion in Category A. 
Unknown 
• 
An association with the study drug cannot be discounted, but other factors 
prevent a conclusion from being drawn. 
Unlikely 
• 
Sufficient information exists to establish beyond reasonable doubt that the 
product was not likely to be the cause of the event. 


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Classification of adverse events 
At the conclusion of the study, Medicinal Dictionary for Drug Regulatory Authorities 
(MeDDRA) terms will be assigned to all adverse events and will be included in the final 
study report.  
Stopping Criteria 
If more than 5 patients report a greater than moderate local side effect (irritation, 
worsening of rash, vesicles/bulla etc) or if the clinical dermatological score in the 
treatment area as assessed by the clinician has worsened by more than 50% from 
baseline in more than 5 patients, then all patients will stop medication until further review 
and changes made to the protocol.  If any unanticipated serious adverse effects are noted 
all subjects will be notified and changes will be made to future protocols and submitted 
for approval. 
6. DATA ANALYSIS AND DATA MONITORING 
Objectives and Endpoints: 
Primary objective & outcome:  
1. To assess the efficacy of Ruxolitinib cream 1.5% on skin lesions in patients with 
Chronic Hand Dermatitis:     
- proportion of patients achieving an Investigators Global Assessment (IGA) score    
of 0 or 1 with at least a 2-step improvement (IGA treatment success) at week 12 
- HECSI-75% from baseline to week 12 
 
Secondary objective & outcome:  
1. To assess the efficacy of Ruxolitinib cream 1.5% on other clinical domains (e.g. 
pruritus, pain, work productivity and activity impairment; daily quality of life index/DLQI, 
Hand Eczema Severity Index/HESI):  
- 
Time to IGA treatment success 
- 
Change in HECSI score from baseline to week 4, 8 and 12. 
- 
Proportion of subjects with a ≥ 2 and ≥ 4-point improvement in Itch 
Numerical Rating Scale (NRS) score from baseline to week 4, 8 and 12.   
- 
HECSI-75% at week 8  
- 
HECSI-90% at week 12 
2. To assess safety and tolerability of Ruxolitinib cream 1.5% in patients with chronic 
hand dermatitis: 
- 
Incidence, frequency and severity of adverse events and laboratory data for 
hematology, serum chemistry and urinalysis 
- 
use of rescue medications 
 
 
Exploratory objective & outcome: 
1. To assess the effect of Ruxolitinib cream 1.5% on patient reported outcomes 
- 
Change from baseline to week 4, 8 and 12 in DLQI 


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- 
Change from baseline to week 4, 8 and 12 in work productivity and activity 
impairment index 
2. To assess the efficacy of Ruxolitinib cream 1.5% on skin barrier integrity in patients 
with Chronic Hand Dermatitis:   
- 
change in transepidermal water loss (TEWL) and barrier integrity score 
(TEWL recovery after tape stripping) and pH from baseline to week 4 and 
end of treatment on perilesion (normal appearing) skin 
3. To identify translational skin biomarkers  
- 
change in the expression of selected biomarkers in skin samples obtained 
from tape stripping (d-squame) at baseline and end of treatment (week 12) 
4. To identify change in microbiome after treatment  
 
Side effects and baseline characteristics will be tabulated qualitatively.  The blinded pre-
vs post evaluation will be analyzed for IGA scores by the Wilcoxon sign-rank test.    
 
Data Storage and Confidentiality 
All data from the clinical trial will be securely stored using the REDCap.  Only the minimal 
necessary data is being collected.  This includes: name, contact information, age, sex, 
MRN, history of allergies, dermatologic diagnosis, history of other medical conditions, 
current medications and clinical scores. Subjects may be asked to sign an Authorization 
for Release/Disclosure of Medical Health Information form if a chart is not established at 
the University of Rochester.  Access to this protected health information will be restricted 
to the principal investigator, sub-investigator and study coordinators.   Information 
obtained will be stored in REDcap.  Samples will be assigned unique identifiers and stored 
separately from the key linking the sample to the identifiers.  The electronic key will be 
stored in REDcap file, accessible only to study personnel.  Any paper documents 
containing identifiers will be kept in a binder in a locked cabinet accessible only to study 
personnel.   
 
Data Monitoring 
The study will be monitored in compliance with the relevant parts of 21 CFR and according 
to the ICH GCP Guidelines. 
Case Report Forms will be completed as information becomes available or within five 
days of a Study Visit. 
 
The Principal Investigator or a Sub-investigator will sign and date the indicated places of 
the Case Report Form.  This signature will indicate that thorough inspection of the data 
therein has been made and will thereby certify the contents of the form.   
 
The procedures outlined in the protocol and case report forms will be carefully reviewed 
by the Sponsor, Investigator and staff prior to Study Initiation to ensure appropriate 
interpretation and implementation.  No deviations from the protocol shall be made except 


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17 
 
in emergency situations where alternative treatment is necessary for the protection, 
proper care and well-being of subjects. 
 
Amendments will be submitted to the IRB for their review and approval prior to 
implementation.  When an amendment to a protocol substantially alters the study design 
or increases potential risk to the study subject, the Informed Consent form will be revised 
and if applicable, subject’s consent to continue participation will again be obtained. 
 
7. SUBJECTS IDENTIFICATION, RECRUITMENT AND CONSENT 
Method of subject identification and recruitment 
Dr. Anna De Benedetto and study team will identify potential subjects in URMC 
dermatology clinics, screening upcoming clinic schedules in eRecord for potential 
eligible subjects with a diagnosis of hand dermatitis as well as referrals from 
dermatologists within URMC dermatology clinics.  The study team may contact the 
potential eligible subjects via telephone call prior to their clinic visit to discuss the study, 
field questions and assess interest. If a patient is found to have a history of diagnosed 
hand dermatitis in which they have been treated at URMC dermatology, as well as a 
history of having been seen by Dr. Anna De Benedetto during a prior clinic visit, the 
potential subject may be contacted via URMC MyChart. If the potential subject is 
interested in participating in the study they will be offered to have the consent form 
mailed or emailed to them to READ ONLY with instructions that the consent is for 
review only.  Prior to the consent being mailed or emailed to the potential subject a 
study team member will cross out the signature page to eliminate confusion.  The 
potential participant will sign a NEW clean consent upon their clinic and/or study visit 
along with the study team member.  
In the case of clinical subjects, Dr. De Benedetto or other URMC faculties will provide the 
subject with a contact phone number for the study coordinator who is approved to enroll 
and consent subjects. While Dr. De Benedetto will be available for questions, consent 
might be obtained by other study personnel for subjects she sees in her clinical practice. 
It will be made clear to the potential subjects that their participation is voluntary and their 
care at the Department of Dermatology will not be affected by their decision to participate 
in this study.  
 
Process of consent  
Dr. De Benedetto or other team members (e.g. coordinator, nurse, co-investigator) will 
meet directly with the subjects in a private suite. The consent form will be discussed 
with the potential subject. Time allotted to consenting will be dependent on the subjects’ 
needs, questions, and comprehension of the information in the consent form.  Each 
subject will be encouraged to read the consent form on his/her own and ask any specific 
questions as well as have the option to take the consent home to review with family 
and/or friends. 
Subjects will be given a copy of the signed consent.  


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18 
 
 
Subject capacity  
We will not be recruiting subject incapable of giving informed consent. 
Subject/representative comprehension  
The subject’s capacity to comprehend the information in the consent form will be 
assessed by asking questions about the content and encouraging the subject to describe 
briefly the study procedures. 
Documentation of consent  
The consent will be documented by signing and dating the consent form by both the study 
subject and the person obtaining consent. A copy of the consent form will be provided to 
the subject. 
Costs to the subject  
Procedures performed during the study will be at no cost to the subject. 
 
Payment for participation  
Subjects that agree to participate in the study will receive compensation for their time:  
$35.00 for the screening visit.  Each complete study visit will be $50.00. For a total of up 
to $285.00 including if all visits are completed.   
 
For this study we use a subject payment system called Advarra Participant Payments. 
The system allows three ways to provide payment. Subjects can choose: a reloadable 
debit card; direct deposit; or mailed paper checks. The study team will help subject 
create a “subject profile” in the system.  In order to provide payment, the subject will 
need to enter their name and date of birth into their subject profile which is required to 
set up a subject account and for customer service purposes.  Depending on which 
payment method is chosen, the subject may also need to enter their email address and 
banking information.  If the subject already has an Advarra account (because they are in 
another study that uses this system), their existing profile will be used to provide 
payment.    
Payments received for participation in research is considered taxable income.  If the 
subject receives $600.00 or more in any one calendar year from UR or its affiliates, the 
University is required to report this information to the Internal Revenue Service (IRS) in 
a 1099 (Miscellaneous Income) form.  The subject will be sent a copy of this form and a 
copy will be sent to the IRS. Depending on the amount the subject is paid, they may be 
asked to submit a W-9 form, which includes their Social Security Number. 
 
Potential benefits to the subjects  
There are no benefits for the individual participant. The investigational medication may 
temporally improve or worsen the lesion in the target area of application. The nature of 
this pilot study does not promise benefit for the individual. We hope that this research will 


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19 
 
lead to a better understanding of atopic dermatitis pathogenesis and pave the way for 
development of topical medications that aim to repair skin barrier and skin driven 
inflammation.  
 
 
 
 
 
 
 
 
 
 
 
 
References 
 
i Br J Dermatol. 2005 Feb;152(2):302-7 
ii Thyssen JP, Johansen JD, Linneberg A, MennéT.  The epidemiology of hand eczema in the general 
population--prevalence and main findings. Contact Dermatitis. 2010;62(2):75.  
iii Kumari V, Timm K, Kühl AA, Heine G, Worm M. Impact of systemic alitretinoin treatment on s  
kin barrier gene and protein expression in patients with chronic hand eczema. Br J Dermatol. 2016 
Dec;175(6):1243-1250. doi: 10.1111/bjd.14921 
iv Bordon Y Neuroimmunological disorders: JAK in the itch. Nat Rev Drug Discov. 2017 Oct 
30;16(11):753. doi: 10.1038/nrd.2017.204. 
v Naydenov NG, Baranwal S, Khan S, Feygin A, Gupta P, Ivanov AI. Novel mechanism of cytokine-
induced disruption of epithelial barriers: Janus kinase and protein kinase D-dependent downregulation of 
junction protein expression. Tissue Barriers. 2013;1(4):e25231.doi: 10.4161/tisb.25231. Epub 2013 Jun 3. 
vi Nassif A, Chan SC, Storrs FJ, Hanifin JM. Abnormal skin irritancy in atopic dermatitis and in atopy 
without dermatitis. Arch Dermatol. 1994 Nov;130(11):1402-7 
vii Br J Dermatol, 2011. 165(2): p. 329-34 
viii Br J Dermatol. 2005 Feb;152(2):302-7 
ix J Am Acad Dermatol. 2003 Jan;48(1):128-30. 
 
 

ICF_001.pdf: 
Department of Dermatology
NCT05293717
CONSENT FORM
to Participate in Research, and
AUTHORIZATION 
to Collect, Use, and Disclose Protected Health Information (PHI)
Study Title:
Topical Ruxolitinib (Jak1/Jak2 inhibitor) in Chronic 
Hand Dermatitis attenuates inflammation and 
enhances skin barrier repair.
Principal Investigator:
(Study Doctor)
Anna De Benedetto, MD 
Telephone:
585-273-4195
585-275-7546 (24 Hours)
Address:
UR Dermatology at College Town
40 Celebration Drive
Rochester, NY 14620
Key Information
•
Being in this research study is voluntary – it is your choice
•
You are being asked to take part in this study because you have Chronic Hand
Dermatitis
•
The purpose of this study is to assess the efficacy of Ruxolitinib cream 1.5% on
skin lesions.
•
Your participation in this study will last for about 16 weeks
•
Procedures will include: reading, signing, and dating this consent form,
assessments, pictures, blood sample, skin barrier measurements, vital signs, and
collecting your current medication list and your medical history.  If you are a
female, we will complete a pregnancy test.
•
There are risks from participating.
o
The most common risks is some pain when the needle goes into your skin
for a blood draw.
o
Risks of medication include irritation, burning or pain, redness, peeling or
stinging, blistering rash or swelling.
o
The more serious risks could involve rare possibility of an allergic reaction to
the tape and infection. See the section: “What side effects or risks can I
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Expiration Date: 4/5/2023


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expect from being in the study” for more information.  You should discuss 
these risks in detail with the study team.
•
You might not benefit from being in this research study.
○   If you do not want to take part in this study you can discuss other options 
with your doctor (for example, injections, creams, light treatments).
GENERAL INFORMATION ABOUT THIS STUDY
1.What is the Title of this research study (this “Research Study”)?
Topical Ruxolitinib (Jak1/Jak2 inhibitor) in Chronic Hand Dermatitis attenuates 
(reduces) inflammation and enhances skin barrier repair.
2. Whom do you call if you have questions about this Research Study (the “Study 
Team”)?
Principal Investigator: Anna De Benedetto, MD   585-275-7546 (24hr Number)
3.  Who is paying for this Research Study?
 
The study is being performed by the University of Rochester and the study drug is being 
provided by the Incyte Corporation at no cost to you.
4. In general, what do you need to know about this Research Study?
Agreeing to become involved in any research is always voluntary.  By signing this form, 
you are not waiving any of your legal rights.  If you decide not to participate in this 
research, you will not be penalized in any way and you will not lose any benefits to 
which you are entitled. If you have questions about your rights as a research subject, 
please call the University of Rochester Research Subjects Review Board at 265 
Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or 
(877) 449-4441 for the following reasons:
• You wish to talk to someone other than the research staff about your rights as a 
research subject;
• To voice concerns about the research;
• To provide input concerning the research process;
• In the event the study staff could not be reached. 
a) In general, what is the purpose of the research, how long will you be 
involved?  
This research study will explore the use of an investigational topical medication to 
reduce itch associated with skin lesions in individuals with chronic hand dermatitis. 
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Ruxolitinib cream is under development for the treatment inflammatory skin 
conditions. Ruxolitinib cream has been recently approved by Food and Drug 
Administration (FDA) for Atopic Dermatitis, which is a condition that makes the skin 
red and itchy.
b) What is involved with your participation, and what are the procedures to be 
followed in the research? 
Participation will include up to 5 study visits over a 4 month (16 weeks) time period.  
You are being asked to apply topical medication to your skin at home and will be 
asked to complete daily study drug diary.  Procedures at each clinic visit include a 
clinical exam with dermatology scoring, which your study team will perform, non-
invasive skin barrier assessments, subject questionnaires, and blood draws (at 
screening and for any unscheduled event if needed).  Urine pregnancy tests will be 
conducted at specified time points for women of child bearing potential and a 
PATCH test for contact allergens may be performed to confirm inclusion.  PATCH 
testing is a test to discover whether a person is allergic to any of several 
substances that are applied to the skin under a patch
c) What are the likely risks or discomforts to you? 
Some of the skin barrier assessments may be uncomfortable and redness/irritation 
may occur at the site of the procedure, usually resolves within 12 hours. The risks 
of drawing blood from a vein may cause pain and bruising at the place where the 
blood was taken. Rarely, some people experience inflammation (swelling) of the 
vein, infection at the site of the blood draw, lightheadedness, or fainting.
Risks associated with the investigational topical product include possible local 
(affects only one part of the body) and rarely a systemic (bloodstream) reactions to 
the medication.
d) What are the likely benefits to you or to others from the research? 
You may or may not benefit from participation in the research.  We do not know the 
impact of its use on the skin lesions and itch.
e) What are the appropriate alternative procedures or courses of treatment, if 
any, that might be helpful to you? 
Your alternative is not to participate.  Standard of care options can be discussed 
with you including other topical products such as topical steroid creams/ointments.
Additional and more detailed information is provided within the remainder of 
this Informed Consent form, please read before deciding if you wish to 
participate in this study
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WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
5. What will be done as part of your normal clinical care (even if you did not 
participate in this Research Study)? 
All procedures are associated with the research study.
6.  What will be done only because you are in this Research Study? 
Study design: This is an open label, single site study and will be conducted at the UR 
Dermatology at College Town.
Study Timeline:
  - Screening visit (-28 days before start of treatment)
- visit 1 --(V1, day 0), start of active treatment; 
- visit 2 – 28 days +/- 3 days (4 weeks) treatment; 
- visit 3 – 56 days +/- 3 days (8 weeks) treatment;
     - visit 4 – 84 days +/- 3 days (12 weeks) end treatment;
- visit 5 – 112 days +/-3 (16 week) follow up
Procedures
Screening visit (-28 days)
1)
Consenting and confirmation of inclusion & exclusion criteria 
2)
Medical history
3)
Physical exam with focus on skin exam 
4)
Collection of concomitant medications
5)
Fasting blood draw for safety laboratories
6)
Urinalysis 
7)
Possible washout period which means the length of time that someone enrolled 
in a study must not receive any treatment before receiving the trial’s 
investigational drug.
8)
Possible schedule PATCH test if investigator believes it is clinical necessary to 
rule out contact dermatitis
9)
Urine pregnancy test for woman of childbearing potential
10)
Schedule visit 1
Visit 1 (Day 0): 
1)
Confirmation of inclusion & exclusion criteria
2)
General History
3) 
Physical Exam 
4)
Review of concomitant medications
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5)
Urine pregnancy test for woman of childbearing potential. Counseling on 
acceptable birth control measures to use throughout treatment period (16 weeks 
or 112 days) and until 30 days after stopping study drug
6)
Clinical score for chronic hand dermatitis, which is a simple way to study the 
course of chronic hand eczema 
7)
Itch and other quality of life assessments 
8)
Digital pictures of the target area/hands
9)
Non-invasive skin barrier measurements: TransEpidermal Water Loss (TEWL) 
and optional pH.  A TEWL test is designed to test whether a skincare or cosmetic 
product is causing transepidermal water loss that is leading to dry skin conditions 
or not.  The optional pH is obtained to evaluate how acidic or alkaline our skin is.  
Skin with a balanced pH is effective at keeping moisture in and harmful bacteria 
out.
10)
Repeated tape stripping from treated area. Serial measurements of TEWL will be 
performed after tape stripping as previously described.  Tape stripping is a simple 
and efficient method for assessing the quality of skin findings. 
11)
Dispense investigational drug for 4 weeks (weight of tube will be recorded at each 
visit)
12)
Provide instructions to complete at home diary.  
13)
Provide date of Visit 2 
14)
Weight of the tube to check to make sure you are taking using the investigational 
cream. 
15)
Skin swabs (optional)
16) 
Skin symptoms questionnaire (optional)
Visit 2 (Day 28 +/-3) & Visit 3 (Day 56 +/-3) and Visit 4 (Day 84 +/-3: 
1)
Review subject diary and address any questions, concerns, or missed doses
2)
Review concomitant medications 
3)
Questionnaire to clinically characterize chronic hand dermatitis, review of 
medications and possible side effects 
4)
Urine pregnancy test for woman of childbearing potential
5)
Clinical score for chronic hand dermatitis
6)
Itch and other Quality of Life assessments, review daily diary 
7)
Digital pictures of the targeted area
8)
Non-invasive skin barrier Measurements: transepidermal water loss/TEWL. 
Optional: pH 
9)
Repeated tape stripping 
10)
Dispense investigational drug 
11)
Review diary instructions
12)
Provide date for next visit 
13)
Weight of the tube to check to make sure you are taking using the investigational 
cream at Visit 2 and Visit 3
14)
Skin swabs (optional)
15)
Skin symptoms questionnaire (optional)
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Visit 5 – 112 +/- 3 days (16 weeks)  
1)
Review subject diary and address any questions, concerns, or missed doses
2)
Review of concomitant medications 
3)
Questionnaire to clinically characterize chronic hand dermatitis, review of 
medications and possible side effects
4
Urine pregnancy test for woman of childbearing potential.
5)
Clinical score for chronic hand dermatitis
6) 
Itch and other quality of life assessments 
7)
Digital pictures of the targeted area
8)
Non-invasive skin barrier measurements: transepidermal water loss. Optional: pH
9)
Repeated tape stripping 
10)
Review diary for completion 
11)
Weigh returned tubes
Unscheduled Visit(s)
If at any time during the duration of the study you do not feel well or if you have any side 
effects, you may be asked to come in to the Dermatology clinic for further evaluation.  During 
this visit you may need to undergo one or more of the procedures described above per the 
discretion of the study team. 
Study procedures & methods
Disease status assessment: 1) Investigator Global Assessment (IGA), which will 
provide information of the overall disease (5-point scale: clear, almost clear, mild, 
moderate, severe) and it is the score requested by U.S Food and Drug Administration 
(FDA) for clinical study.  2) Hand Eczema Severity Index (HECSI), a well-accepted and 
validated scoring system for disease activity. It incorporates both the extent and the 
intensity of the disease. 
The presence or absence of skin irritation (e.g. distinct spots, and/or small, solid, usually 
with slight elevation of skin), redness, atrophy (waste/wither away) and telangiectasia 
(dilation of capillaries) will be noted at each study visit. 
- The pruritus (itching) intensity will be assessed using Itch Numerical Rating Scale 
(NRS; see appendix). 
- You will be asked to rate the intensity of their itch using this scale. The Dermatology 
Life Quality Index (DLQI) measures 6 disease-specific domains (symptoms and 
feelings, leisure, daily activities, work and school, personal relationships, and treatment) 
during the last week; individual items were summed to generate an overall score. Data 
will be reported as change from baseline to week 8 in DLQI. 
-The Work Productivity and Activity Impairment-Chronic Hand Dermatitis (WPAI-CHD) 
questionnaire asks the number of work hours missed, hours worked, and impairment 
while working/performing usual daily activities as a result of chronic hand dermatitis 
during the past 7 days. 
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- Digital pictures: A digital picture will be taken with a dedicated digital camera in our 
clinic. The pictures will be labeled with your study ID and date. Pictures will not include 
identifying information (for example: facial features, tattoo, etc.). Digital photographs will 
be used to record the location and monitor the size of target lesions.  Your photographs 
may be used for educational purposes including but not limited to publication(s) and/or 
lecture(s).
- Blood sample: blood will be obtained for safety laboratories and to evaluate 
biomarkers (biological molecule found in the blood, body fluids or tissues that is the sign 
of a normal or abnormal condition) of disease severity. 
- Skin barrier measurements: Transepidermal water loss/TEWL, +/- pH is a 
measurement that assess the dryness and health of the skin.  The assessment will be 
obtained from a treatment area of an area around a lesion and on a site of inflammation. 
For each of the specific measurements, a probe will be gently applied on the skin 
surface for up to 1 minute. You will be comfortable in the room in which you are being 
tested to ensure that sweating due to stress or adjusting to the temperature does not 
alter the TEWL. 
Skin barrier integrity assessment: the most superficial layers of the skin will be 
collected by tape stripping. This is a well-established method used in clinical research 
to gently disrupt the skin barrier. The first tape will be discarded to eliminate dirt and 
residue of skin products. Each tape will be gently pressed against the skin with uniform 
pressure for 5-10 seconds using a probe that measures skin hydration. You will have 5 
consecutive tapes collected from lesional skin and 20 consecutive tapes from non-
lesional skin. TEWL will be measured after each set of 5 tape strippings. These 
measurements should provide data to determine if the treatment has an effect on skin 
barrier integrity.
Skin sampling for biomarkers: we will use the tape stripping to collect the outermost 
layer of the skin at baseline and at 16 weeks to identify possible biomarkers.
Prohibited 
Medications 
and 
procedures: 
use 
of 
topical 
or 
systemic 
immunosuppression/immunomodulators medications and Phototherapy is not 
permitted during the study. Your medication list will be reviewed at each study visit.  
Hand surgery or other procedures (including but not limited to cryotherapy (cold 
therapy), ED&C (electrodesiccation and curettage which is a surgical procedure), skin 
biopsy) are not allowed during the study. If medically necessary, the investigator will 
withdraw you from the study.
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Once this research study is completed, any information that could identify you will be 
removed from any identifiable private information or identifiable biospecimens collected. 
After such removal, the information or biospecimens could be used for future research 
studies or distributed to another investigator for future research studies without 
additional informed consent from you or your legally authorized representative.
If you have any questions now or at any time during this Research Study, please contact 
one of the Research Team members listed in question 3 of this form.
7.
What identifiable health information will be collected about you and how will it 
be used?
The Research Team will collect demographic information, results of physical exams, 
blood tests, and other diagnostic and medical procedures, as well as medical and 
medication history.
The Research Team may collect this information from other healthcare providers, 
such as laboratories, which are a part of this research, as well as healthcare providers 
that are not part of this research (other doctors, hospitals or clinics). Other 
professionals at UR Dermatology at College Town who provide study-related care, 
and the URMC Institutional Review Board (IRB), may also collect your health 
information. 
The Research Team listed in question 3 above will use or share your health 
information as described below to carry out this research study. 
8. With whom will this health information be shared?
This health information may be shared with:

The University of Rochester 

Incyte Corporation (who is providing the drug)   (listed in Question 3 of this form);

United States governmental agencies which are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections;

Government agencies which are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments;

The IRB that reviewed this Research Study and ensures your rights as a Study 
Subject are protected. 
Otherwise, your identifiable health information will not be shared without your 
permission unless required by law or a court order. Once your health information is 
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shared with those listed above, it is possible that they could share it without your 
permission because it would no longer be protected by the federal privacy law. 
 
9. How long will you be in this Research Study?
Your involvement in this study will last approximately 5 months.
This Authorization to use and share your health information expires at the end of the 
study, unless you revoke it (take it back) sooner.
10.How many people are expected to take part in this Research Study?
We hope to enroll 15 subjects in this clinical trial.
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WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
11. What are the possible discomforts and risks from taking part in this Research 
Study?
Risks Associated with Digital Picture
There are no known risks for the digital picture. The image will not include identifying 
features (for example: facial features, tattoo, etc.) and will be labeled with your subject 
ID and date. Pictures will be taken with a dedicated camera and stored on a secure 
server.
Risks Associated with Barrier Assessments
There are no known risks for the barrier assessments.
Risks Associated with Tape Stripping
The risks associated with tape stripping, include the rare possibility of an allergic reaction 
to the tape and infection.  Since the tape is removed immediately after application, the 
risk of reaction is extremely low.  If you have a known allergy to tapes or adhesive 
material, you should not participate. In previous and ongoing studies involving tape 
stripping, it has been noted that a very mild redness may develop immediately after a 
series of tape stripping on one localized area of skin, probably due to the mild irritation 
to the skin.  The redness is expected to resolve within 12 hours without issue.  The risk 
of skin infection is extremely low since only the top skin layers are recorded with tape.  
You will be provided with wound care information and a department phone number to 
contact should you have any concerns. 
Risks of Phlebotomy
The risks of having blood drawn include some pain when the needle goes in, and a small 
risk of bruising and/or infection at that site. You may feel lightheaded, nauseous, or faint. 
4mLs is approximately 1 teaspoon of blood and is not likely to cause lightheadedness, 
however you will be observed after blood draw to be sure you are comfortable with 
walking. You will be encouraged to drink plenty of water prior to the blood draw. 
Phlebotomy will be performed at the elbow pit to minimize pain and bruising. You will 
be seated during the blood draw to minimize dizziness and any risk of falling. Pressure 
will be applied to the site after the draw and a Band-Aid will be applied to minimize the 
risk of bleeding and infection.
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Risks of Ruxolitinib 1.5% cream 
Based on human and animal studies, there is a low potential for irritation or skin changes 
following the cream application. Skin-related adverse reactions in clinical studies have 
been seen with similar frequency in ruxolitinib, and control-treated lesions, have been 
mild, have not resulted in discontinuation of study medication, and usually have 
resolved with continued application.

You may experience some irritation, burning or pain from the Ruxolitinib 1.5% 
cream especially in areas of open skin from scratching. You may experience 
redness, peeling, pain, stinging or burning sensation in the area. You might also 
experience a blistering rash or swelling. You may experience increased dryness 
from the cream formulation.  
U.S. Public Law 110-85 requires registration of "Applicable Clinical Trials" at 
www.ClinicalTrials.gov.  A description of this clinical trial is available on 
http://www.ClinicalTrials.gov, as required by U.S. Law. The Clinical Trials.gov identifier 
number is NCT05293717.  This Web site will not include information that can identify you.  
At most, the Web site will include a summary of the results.  You can search this website 
at any time. 
Based on FDA approved medication label information, risks include: 

Developing serious infections that may lead to hospitalization or death

Reported infections include:
o
Active tuberculosis (TB), which may present with pulmonary or 
extrapulmonary disease
o
Invasive fungal infections (e.g., candidiasis, pneumocystosis)
o
Bacterial, viral, and other infections due to opportunistic pathogens
o
Thrombocytopenia (low platelet count), anemia (lack of healthy red blood 
cells) and neutropenia (too few white blood cells)

If you have an active, serious infection, including localized infections you should not 
participate.  You will be closely monitor for developing signs and symptoms of 
infection during and after treatment
You should moisturize in the morning and use gentle body wash to minimize these 
potential side effects. 
In case of any abnormal reaction you can call the UR Dermatology clinical trials office 
(clinical coordinator: 585-275-9577 or main office: 585-275-7546) and stop using 
Ruxolitinib 1.5% cream until discussing symptoms with study team. 
Oral ruxolitinib may have effects on the immune system depending primarily upon the 
level (drug concentrations in blood) and the duration of exposure to it. Topical (skin 
application) treatment is not anticipated to result in any meaningful systemic (blood) 
exposure to ruxolitinib. However, absorption through damage skin could result in 
increased localized absorption that could possibly reduce your ability to fight infections, 
if such external treatment is continuous in nature and longer term (for example: for 
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months rather than weeks and on large area of body). In such situations, monitoring of 
possible skin infections or skin cancers is recommended for ruxolitinib cream. You will 
be monitored closely for signs and symptoms of skin infections or cancers in the treated 
areas.  If you have evidence of active infection or skin cancer, you will not be eligible to 
take part in the study.
There is a potential risk of reversible decreases in the levels of cells in the blood (for 
example: platelets, white blood cells, or red blood cells). This risk is low because we 
expect minimal to no absorption from the skin and the application will be limited to the 
hands only. No clinically significant decreases in platelet counts have been noted in the 
completed or ongoing studies with ruxolitinib cream. 
Previous tolerability in healthy individuals demonstrated that ruxolitinib 1.5% cream was 
not phototoxic (a condition in which the skin or eyes become very sensitive to sunlight 
or other forms of light) and did not induce photosensitization. However, due to the 
potential risk of skin reaction when exposure to ruxolitinib is combined with sun 
exposure, you should avoid prolonged exposure to either natural or artificial sunlight 
(including tanning booths, sun lamps, etc.) and use sunscreen when outdoor for a 
prolonged period of time. 
Risks to children or pets are not known and you should keep the study cream out of 
reach from children and pets. 
Because this is an investigational medication/formulation some side effects may not yet be 
known. Any adverse reaction will be counted.
Reproductive Risks 
Ruxolitinib should not be used by pregnant women, as there are inadequate prenatal 
and postnatal data in humans. If you are a woman of child bearing potential, you will be 
counseled to use acceptable birth control methods. You cannot participate in this study 
if you are pregnant, become pregnant, or are nursing an infant.
General Risks
This Research Study may also include risks that are unknown at this time.
Please note, participating in more than one research study or project may further 
increase the risks to you.  If you are already enrolled in a research study, please inform 
one of the Research Team members listed in question 3 of this form or the person 
reviewing this consent with you before enrolling in this or any other research study or 
project.
During the study, the Research Team will notify you of new information that may 
become available and might affect your decision to remain in the study. 
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When participating in any research study there is a possibility for invasion of privacy or 
breach of confidentiality.  Because we will be collecting personal, identifiable  
information  about  you,  there  is  a potential for invasion of privacy or breach in 
confidentiality. To minimize this risk, we will assign you a study number/identifier instead 
of labeling the information we collect from you with your name or medical record 
number. Further, any research performed, or data generated, will be linked with your 
assigned study number and not with any personally identifying information. All the 
information we collect that is personally identifiable will be stored in a secure manner 
and only study team members will have access to it. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the Research Team members listed in question 
3 in this form.
12a. What are the potential benefits to you for taking part in this Research Study?
You may or may not benefit from participation in this clinical trial. The investigational 
medication may temporally improve or worsen the dermatitis on your hands.  The nature 
of this exploratory study does not promise benefit for the individual.  
12b. How could others possibly benefit from this Research Study?
We hope that this research will increase our understanding of hand dermatitis and 
hopefully will lead to development of new therapies aiming at repairing skin barrier and 
skin driven inflammation.
12c. How could the Research Team members benefit from this Research Study?
In general, presenting research results helps the career of a researcher. Therefore, the 
Research Team listed in question 3 of this form may benefit if the results of this 
Research Study are presented at scientific meetings or in scientific journals.
12d. Will you be allowed to see the research information collected about you for 
this Research Study? 
Results from blood work for clinical safety labs and physical exam may be shared with 
you at your next study visit.  Other Information collected about you may be shared with 
you at the end of the study. 
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13. What other choices do you have if you do not want to be in this study? 
Your alternative is not to participate.  Standard of care options can be discussed with 
you including other topical products such as topical steroid creams/ointments.
You may also refuse to authorize the use of your health information, but if you refuse, 
you may not be allowed to be in this research study or receive any research-related 
treatment that is only available in this research study. However, your decision not to 
sign this Authorization will not affect any other treatment you may be eligible to receive.
14a. Can you withdraw from this study? 
You may withdraw your consent and stop participating in this Research Study at any 
time.  If you do withdraw your consent, there will be no penalty to you, and you will not 
lose any benefits to which you are otherwise entitled. 
If you decide to withdraw your consent to participate in this Research Study for any 
reason, please contact the Research Team listed in question 3 of this form. They will 
tell you how to safely stop your participation.
You can also change your mind and take back this Authorization at any time by sending 
a written notice to the Research Team listed in question 3 of this form to let them know 
your decision. If you take back this Authorization, the Research Team may only use and 
disclose your health information already collected for this research study. No additional 
health information about you will be collected or disclosed to the Research Team. 
However, if you take back this Authorization, you may not be able to continue in this 
study. Please discuss this with a member of the Research Team listed in question #3.
14b.Can the Principal Investigator withdraw you from this Research Study? 
You may be withdrawn from this Research Study without your consent for the following 
reasons:

The PI or Sub-Investigator believes it is in your best interest

The sponsor stops the study
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WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
15. If you choose to take part in this Research Study, will it cost you anything?
No, there will be no additional costs to you or your health plan as a result of your 
participation in this study. However, if you feel you have received a bill related to this 
study, please contact the Principal Investigator.
If you receive any healthcare at UR Dermatology at College Town is not related to this 
study, this care will be billed as usual.
16. Will you be paid for taking part in this Research Study?
You  will  receive  $35.00  for  screening  and  $50.00  for  all  other  visits  after  that  
that  are completed. You will only receive payment for each completed study visit.  You 
will not be paid for visits that you do not complete.  
For this study we use a subject payment system called Advarra Participant Payments. 
The system allows three ways to provide payment. You can choose: a reloadable debit 
card; direct deposit; or mailed paper checks. The study team will help you create a 
“subject profile” in the system.  In order to provide payment, you will need to enter 
your name and date of birth into your subject profile which is required to set up a 
subject account and for customer service purposes.  Depending on which payment 
method you choose, you may also need to enter your email address and banking 
information.  If you already have an Advarra account (because you are in another 
study that uses this system), your existing profile will be used to provide payment.  
See the ‘Information Sheet for Advarra Participant Payments” for additional 
information. 
Payment  received  for  participation  in  research  is  considered  taxable  income.    If  
you receive  payment  for  your  participation  in studies  at  the  University  of Rochester 
and  its affiliates of $600.00 or more in any one calendar year, the University is required 
to report this information to the Internal Revenue Service (IRS) in a 1099 (Miscellaneous 
Income) form.  You will be sent a copy of this form and a copy will be sent to the IRS. 
Depending on the amount you are paid, you may be asked to submit a W-9 form, which 
includes your Social Security Number.
What if you are injured while in this Research Study? 
  
If you are directly injured by the Ruxolitinib 1.5% cream being studied, or by medical 
procedures needed because of this study, and you receive medical care for the injury, 
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you may need to pay for that care.  You will be reimbursed for reasonable and necessary 
medical costs for such care, but you might not be reimbursed for care covered and paid 
for by a third party like your health insurance provider, or costs such as required co-
payments or deductibles related to that coverage.  No other funds have been set aside to 
pay for such things as lost wages or expenses due to a current underlying illness or 
condition.
If your research injury is paid for by the University, we will collect your name, date of birth, 
gender, and Medicare Health Insurance Claim Number or Social Security Number to 
determine your Medicare status. This information will be used only in accordance with the 
law. If you are a Medicare beneficiary, information about the study you are in, and any 
payments made related to your injury, will be reported to the Centers for Medicare & 
Medicaid Services (CMS), in accordance with CMS requirements.  This information will 
not be used for any other purpose.
CONFIDENTIALITY OF RECORDS AND AUTHORIZATION TO USE AND DISCLOSE 
INFORMATION FOR RESEARCH PURPOSES 
The University of Rochester makes every effort to keep the information collected from 
you private. In order to do so, we will code all samples and questionnaires collected; allow 
access to study records to only those involved in the study; retain all study related 
documents in a secure, locked location, giving access to only those who are involved in 
the study. All study data collected will be identified by a code number and your identity 
will remain unknown. All information, which is collected about you as well as collected 
samples that leave the clinic, will have your name removed so that you cannot be 
recognized by it. The study doctor will be responsible for keeping a code list which would 
make it possible to link your assigned number to your name. This will be kept in a safe 
place to ensure that in case of an emergency you can be identified and contacted. The 
code list will be kept until the last marketing application has been received for the study 
drug. Sometimes, however, researchers need to share information that may identify you 
with people that work for the University, regulators or the study sponsor. If this does 
happen we will take precautions to protect the information you have provided.  Results of 
the research may be presented at meetings or in publication, but your name will not be 
used.  
If you have never received a copy of the University of Rochester Medical Center (URMC) 
and Affiliates Notice of Privacy Practices, please ask the investigator for one
What information may be used and given to others?  The study doctor will get your 
personal and medical information. 
For example: 
•
Research records 
•
Records about phone calls made as part of this research 
•
Records about your study visits 
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•
Past and present medical records related to the study, including records of 
external providers that are available via your electronic health record at URMC 
& Affiliates 
•
Results of medical tests
Who may use and give out information about you? 
•
The study doctor and the study staff 
•
URMC and Affiliates 
Your information may be given to: 
•
The Department of Health and Human Services 
•
The University of Rochester 
•
The study sponsor, its representatives “sponsor” and their business partners.  
•
The U.S. Food and Drug Administration (FDA) may also need to inspect study 
and copy records at some point during the study or even after it has been 
completed. In the event that this should occur, every effort will be made to keep 
identifying information about you private. However, absolute confidentiality 
cannot be guaranteed. 
Why will this information be used and/or given to others? 
o
To do the research 
o
To study the results 
o
To see if the research was done correctly 
If the results of this study are made public, information that identifies you will not be used. 
Financial 
Disclosure
Dr. De Benedetto has received consulting fees from the sponsor in the past 12 
months.  Please feel free to ask any further questions you might have about this 
matter.
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
May I review or copy my information?  Yes, but only after the research is over.
How long will this permission be valid?  This permission will last indefinitely. 
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May I cancel my permission to use and disclose information? 
Yes. You may cancel your permission to use and disclose your health information at any 
time. You do this by sending written notice to the study doctor at the address listed on 
page one. Upon receiving the written notice, the study team will no longer use or disclose 
your health information and you will not be able to stay in this study. Information that has 
already been gathered may need to be used and given to others for the validity of the 
study.
May I withdraw from the study? 
Yes. If you withdraw your permission to be in the study, no new health information 
identifying you will be gathered after that date. Information that has already been gathered 
may still be used and given to others. 
Is my health information protected after it has been given to others? 
No. There is a risk that your information will be given to others without your permission.
RETURN OF INDIVIDUAL RESULTS 
If individual research results about you become available, do you want us to contact you 
and ask whether you want to receive the results?
Yes         No
CONSENT TO FUTURE USE OF INFORMATION / SAMPLES 
May we share  your  samples,  health  information,  with  other researchers to study hand 
dermatitis?
Yes      No
May we share your samples, genomic data, and health information with other researchers 
for future research projects related to other topics?
Yes       No
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SIGNATURES
Subject Consent
I have read (or have had read to me) the contents of this consent form and have been 
encouraged to ask questions.  I have received answers to my questions.  I agree to 
participate in this study.  I have received (or will receive) a signed copy of this form for 
my records and future reference.
______________________________________
Subject Name (printed by subject)
______________________________________
_____________
Signature of Subject
Date
Person Obtaining Consent
I have read this form to the subject and/or the subject has read this form.  I will provide 
the subject with a signed copy of this consent form.  An explanation of the research 
was given and questions from the subject were solicited and answered to the subject’s 
satisfaction.  In my judgment, the subject has demonstrated comprehension of the 
information.  I have given the subject adequate opportunity to read the consent before 
signing.
______________________________________
Name and Title (print)
______________________________________
_____________
Signature of Person Obtaining Consent
Date
RSRB Approval Date: 10/5/2022
Expiration Date: 4/5/2023