I am trying to submit an approval for a medical study with the company Incyte.  The project is regarding the checkpoint mechanism of ruxolitinib 1.5% cream (opzelura). I had proposed to them a study to use this medication (the makers of Opzelura- topical ruxolitinib)––now FDA approved for vitiligo––in patients with immune checkpoint inhibitor induced vitiligo. Traditionally, since 2011, this topical agent has been proven to treat immune checkpoints for metastatic cancers. 

This study involves administering drug or performing non-SOC monitoring/diagnostic procedures.
Study type: interventional
Therapeutic area: dermatology
Requested resource: Incyte Product, Monetary Support
Incyte Drug used for the stud: Topical ruxolitinib (INCB18424) 1.50% 60g CREAM
Where will this trial take place?: United states in a singe center, UT MD Anderson Cancer Center
Total number of subjects: 20

Method: 
Key exclusion criteria were the presence of complete leukotrichia within any facial lesions, dermatologic disease confounding vitiligo assessment, previous use of JAK inhibitor therapy, and use of the following therapies for vitiligo before baseline: any biological or experimental therapy within 12 weeks (or 5 half-lives), phototherapy within 8 weeks, immunomodulating treatments within 4 weeks, or topical treatments within 1 week 
Patient progress on their face will be done through vitiligo area scoring index (VASI), Body Surface Area (BSA), Photography, Physician’s Global Vitiligo Assessment (PhGVA), Patient’s Global Vitiligo Assessment (PhGVA), and VitiQoL questionaire.
 
Assessments: 
● The primary endpoint was the proportion of patients achieving ≥75% improvement from baseline in F-VASI score (F-VASI75) at Week 24 
● Key secondary endpoints were: 
•	Proportion of patients achieving ≥50% and ≥90% improvement from baseline in F VASI score (F-VASI50 and F-VASI90, respectively) at Week 24 
•	Proportion of patients achieving ≥50% improvement from baseline in T VASI (T-VASI50) at Week 24 
•	Proportion of patients achieving a Vitiligo Noticeability Scale (VNS) rating of “a lot less noticeable” or “no longer noticeable” at Week 24 
•	Percentage change from baseline in facial BSA (F-BSA) at Week 24 
•	Safety and tolerability were also assessed as a secondary endpoint.
 
Here is the INCLUSION criteria:
1.	Male or female subjects between 18-65 years of age, inclusive, at time of informed 
Consent; 
2.	Age ≥18 years at the time of signing the ICF; 
3.	Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; 
4.	Subject can understand and sign the ICF, can communicate with the Investigator, can 
understand and comply with the requirements of the protocol, and can apply the study 
drug by himself/herself or has a care giver that can apply the drug; 
5.	Willing and able to comply with scheduled visits, treatment plan, laboratory tests and 
other study procedures; 
6.	Female subjects of childbearing potential and at risk for pregnancy must agree to use 
one method of contraception (per Section XXX) throughout the study and for at least 
28 days after the last dose of assigned treatment; 
Female subjects of non-childbearing potential must meet at least 1 of the following 
criteria: 
a. Achieved postmenopausal status, defined as follows: cessation of regular menses 
for at least 12 consecutive months with no alternative pathological or 
physiological cause; status may be confirmed with a serum follicle-stimulating 
hormone (FSH) level confirming the postmenopausal state; 
b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; 
c. Have medically confirmed ovarian failure. 
All other female subjects (including female subjects with tubal ligations) are 
considered to be of childbearing potential. 
7.	Clinical diagnosis of immune checkpoint inhibitor induced vitiligo; 
Immune checkpoint inhibitors can include: anti-CTLA4, anti-PD1, anti-PDL1 drugs 
Including, but not limited to: (Ipilimumab, Cemiplimab, Dostarlimab, Nivolumab, Pembrolizumab, Atezolizumab, Avelumab, Durbalumab, Relatlimab) 
8.	Last infusion was > 3 months from Baseline; 
9.	Facial lesions have to be stable for 4 weeks 
10.	BSA ≥0.1% involvement on the face excluding involvement at vermilion (confirmed by photographs at Screening Visit);  
11.	Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources other than provided/requested by the study team during the study (Section XXX Lifestyle Requirements); 
 
  
Here is the EXCLUSION criteria: 
1.	Other acute or chronic medical or laboratory abnormality that may increase the risk 
associated with study participation or investigational product administration or may 
interfere with the interpretation of study results and, in the judgment of the 
investigator or sponsor, would make the subject inappropriate for entry into this 
study; 
2.	Abnormal labs: 
Absolute neutrophil count of <2.5 x 109/L (<2500/mm3); 
Hemoglobin <10.0 g/dL or hematocrit <30%; 
· Platelet count below the lower limit of normal (LLN) at Screening; 
· Absolute lymphocyte count of <0.8 x 109 /L (<800/mm3); 
· Serum creatinine > upper limit of normal (ULN) or eGFR <60 ml/min/1.73m2 
based on the age appropriate calculation; 
· Enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 
values >2 times the ULN; 
· Total bilirubin ≥1.5 times the 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; 
· Creatine kinase (CK) >3 times the ULN and positive urine myoglobin; 
· Glycosylated hemoglobin A1c (HbA1c) >10%; Subjects whose diabetes mellitus 
is poorly controlled should be excluded; 
· In the opinion of the investigator or (INSERT SPONSOR XXX) (or designee), have any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject’s participation in the study. 
3.	Subjects that have other types of vitiligo (including but not limited to segmental 
vitiligo); 
4.	Currently have active forms of other hypopigmentation (including but not limited to 
Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma 
and mycosis fungoides], post-inflammatory hypopigmentation, pityriasis alba [minor 
manifestation of atopic dermatitis], senile leukoderma [age-related depigmentation], 
chemical/drug-induced leukoderma, ataxia telangiectasia, tuberous sclerosis, 
melasma, and congenital hypopigmentation disorders including piebaldism, 
Waardenburg syndrome, hypomelanosis of Ito, incontinentia pigmenti, 
dyschromatosis symmetrica hereditaria, xeroderma pigmentosum, and nevus 
depigmentosus); 
Note: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted 
5.	Currently have active forms of inflammatory skin disease(s) or evidence of skin 
conditions (including but not limited to morphea, discoid lupus, leprosy, syphilis, 
psoriasis, seborrheic dermatitis) at the time of the Screening or Day 1 Visit that in the 
opinion of the investigator would interfere with evaluation of vitiligo or response to 
treatment; 
6.	Have received any of the following treatment regiments specified in the timeframes 
outlined below: 
At any time: 
· Use of permanent depigmentation treatment for vitiligo and/or other types of 
pigmentation disorders (eg, monobenzone or phenol). 
Within 6 months of Day 1: 
· Any cell-depleting agents including but not limited to rituximab: within 
6 months of Day 1, or 5 half-lives (if known), or until lymphocyte count 
returns to normal, whichever is longer. 
Within 12 weeks of Day 1: 
· Use of oral JAK inhibitors. Other biologics: within 12 weeks of Day 1 or 5 half-lives (if known), whichever is longer. 
Within 8 weeks of Day 1: 
· Systemic treatments that could affect vitiligo within 8 weeks of Day 1 or 
within 5 half-lives (if known), whichever is longer. 
· Use of oral immune suppressants (eg, cyclosporine A, azathioprine, 
methotrexate [MTX], sulfasalazine, systemic corticosteroids, 
mycophenolate-mofetil,) within 8 weeks of Day 1 or within 5 half-lives (if 
known), whichever is longer. 
· Intralesional steroid injection within 8 weeks of Day 1 or within 5 half-lives 
(if known), whichever is longer. 
· Participation in other studies involving investigational drug(s) within 8 weeks 
of Day 1 or within 5 half-lives (if known), whichever is longer and/or during 
study participation. 
Note: Any investigational or experimental therapy taken or procedure performed 
for vitiligo and other diseases including but not limited to rheumatoid arthritis, 
psoriasis, alopecia areata, thyroid disease, allergic rhinitis, or atopic dermatitis 
within the previous 1 year should be carefully evaluated. Subjects cannot 
participate in studies of other investigational or experimental therapies or 
procedures at any time during their participation in this study. 
Within 6 weeks of Day 1: 
· Live or attenuated live vaccine. 
Within 4 weeks of Day 1: 
· Ultra-Violet B (UVB) phototherapy, Psoralen Ultra-Violet A therapy, or other 
phototherapy. 
Within 2 weeks of Day 1: 
· Topical treatments (including JAK inhibitors) that could affect vitiligo 
(eg, corticosteroids, vitamin D3, and calcineurin inhibitor). 
Within 1 week of Day 1: 
· Herbal medications with unknown properties or known beneficial effects for 
vitiligo. 
7.	Pregnant female subjects; breastfeeding female subjects; and female subjects of 
childbearing potential who are unwilling or unable to use one method of 
contraception as outlined in this protocol for the duration of the study and for at least 
28 days after the last dose of investigational product; 
8.	Have current or recent history of clinically significant severe, progressive, or 
uncontrolled renal (including but not limited to active renal disease or recent kidney 
stones), hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, 
cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or 
have any other severe acute or chronic medical or psychiatric condition or laboratory 
abnormality that may increase the risk associated with study participation or 
investigational product administration, or interfere with the interpretation of study 
results; history of severe allergic or anaphylactoid reaction to kinase inhibitors; or in 
the opinion of the investigator, the subject is inappropriate for entry into this study, or 
unwilling/unable to comply with Section 6 Study Procedures and Section XXX 
Lifestyle Requirements. 
9.	Have a history of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) 
related lymphoproliferative disorder, history of lymphoma, history of leukemia, or 
signs and symptoms suggestive of current lymphatic or lymphoid disease; 
10.	Active infection; 
11.	Significant skin disease within the same body areas planned for study drug application; 
12.	Any condition which, in the opinion of the Investigator, places the subject at 
unacceptable risk if he/she were to participate in the study; 
13.	Treatment with any other topical medication (other than those listed in bullets XXX) 
applied to the face, neck, or upper portion of the anterior or posterior chest within 7 days 
prior to Baseline (Day X). Moisturizers that contain no pharmaceutical active ingredient 
other than the moisturizer will not be considered a medication and will not be a reason for 
exclusion; 
14.	Known hypersensitivity to the inactive ingredients of the study drug (active or placebo); 

I need you to come up with a background and hypothesis for this project. please use NCBI or pubmed articles to make your claims in your writing. From there, use in-text citations and cite every claim.