Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Phase: NA
Conditions: Vitiligo, Dermatology/Skin - Other
Sponsor: Johns Hopkins University

 
 
 
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Study Title: Early Molecular Changes in Vitiligo After 
Narrowband Ultraviolet Therapy 
 
 
 
NCT No.: NCT03270241 
 
 
 
04/12/2018 
 
 
 

 
 
 
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Date: 04/12/2018  
Principal Investigator: Noori Kim, MD 
Application Number: IRB00133884 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
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in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
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1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Vitiligo is a chronic acquired inflammatory skin disease reportedly affecting approximately 1% of 
the world’s population. Patients with vitiligo often experience emotional disabilities that can 
severely impact their quality of life. There have been several studies that demonstrate the negative 
impact that vitiligo has on quality of life, which are comparable to other chronic skin diseases like 
atopic dermatitis, psoriasis, and acne. While the exact etiology of vitiligo is unknown, both the 
humoral and cellular immunity are believed to contribute to the pathogenesis of the disease. 
Histological and molecular differences are also observed between normal and vitiligo skin. 
Currently, narrow-band UVB (NB-UVB) irradiation, is the most common medical therapy available 
for vitiligo. NB-UVB has been observed to stimulate melanocyte migration and proliferation and 
exihibit immune-modulating effects. 
 
Previous research studies observed that long-term NB-UVB phototherapy on vitiligo skin have 
demonstrated effectiveness and safety, both visually and molecularly.  The current study aim to 
evaluate the molecular and histological impact of short-term NB-UVB treatment. We will perform 
patient and clinical evaluations along with skin biopsies from normal and vitiligo skin. We 
hypothesize after one week of NB-UVB treatment, there will be observable molecular changes in 
vitiligo-treated skin when compared to vitiligo untreated and normal skin.  
 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Primary Objective: To evaluate the molecular changes from NB-UVB in Vitiligo treatment 
Secondary Objective: To identify potential targets for further study and for treating Vitiligo. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Vitiligo is a chronic acquired inflammatory skin disease reportedly affecting approximately 1% of 
the world’s population (Kyriakis KP et al, 2009; Taieb A, 2007). Vitiligo remains primarily a 
clinical diagnosis ad can be made with the help of the Wood’s lamp, which is a handheld Ultraviolet 
(UV) irradiation device that emits UVA waves at 365 nm. The Wood’s lamp can be particularly 

 
 
 
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helpful in determining the extent of vitiligo and assess the response to therapy (Gawkrodger DJ et 
al, 2008). Additionally, histopathology can confirm the diagnosis, usually showing few or absence 
of melanocytes and a sparse inflammatory cell infiltrate (Kim YC et al, 2008). 
 
Patients with vitiligo often experience emotional disabilities that can severely impact their quality of 
life. There have been several studies that demonstrate the negative impact that vitiligo has on 
quality of life, which are comparable to other chronic skin diseases like atopic dermatitis, psoriasis, 
and acne. (Kent G et al, 1996; Radtke MA et al, 2009; Talsania N et al, 2010; Ongenae K et al, 
2009; Linthorst Homan MW et al, 2009; Parsad D et al, 2003) The most commonly applied metric 
is the Dermatology Life Quality Index (DLQI), a widely accepted and validated dermatology-
specific patient quality of life assessment. This questionnaire consists of 10 questions evaluating 
social and functional impairments related to skin disease, based on a score ranging from 0 (no 
impairment) to 30 (severe impairment). (Finlay AY et al, 1994) Vitiligo has also been associated 
with psychiatric morbidity which can translate to significant psychosocial burden and functional 
disabilities. (Sampogna F et al, 2004; Mattoo SK et al, 2002; Mattoo SK et al, 2001) The Skindex-
29 provides another validated quality-of-life metric that may address more of the emotional and 
psychosocial impact of the skin disease and has been applied in few vitiligo studies. (Ahmed A et 
al, 2013; Linthorst Homan MW et al, 2009) 
 
While the exact etiology of vitiligo is unknown, the autoimmune hypothesis is the most supported. 
Both humoral and cellular immunity may contribute to the pathogenesis of the disease. Non-specific 
antibodies to the cell surface and intracellular pigment and non-pigment cell antigens have been 
found in the sera of the vitiligo patients. There had been evidence that melanocytes may be 
preferentially more susceptible to the immune-mediated injury than the other cell populations in the 
epidermis, keratinocytes and fibroblasts, ultimately leading to the vitiligo phenotype (Bystryn JC, 
1989; Norris DA et al, 1988). Moreover, the increased levels of melanocyte-specific auto-reactive 
CD8+T cells that seem to correlate with disease severity have been shown in the peripheral blood of 
the vitiligo patients (Ogg GS et al, 1998; Palermo B et al, 2001; Lang KS et al, 2001). Recently, 
mouse models for vitiligo demonstrate that these auto-reactive T cells produce interferon gamma 
(IFN-gamma), which may be a crucial component to the migration and accumulation of the 
melanocytes-specific CD8+ T cells (Harris JE et al., 2012).  
 
Histological and molecular analysis of vitiligo show impaired and absence of melanocytes, 
supported by molecular changes, such as the absence of KIT receptor, a protein expressed early in 
melanocyte differentiation, in vitiligo patients (Gokhale BB and Mehta LN, 1983). Perivascular 
inflammatory cell infiltrates have also been observed. Additional molecular difference between 
normal and vitiligo skin include decrease of stem cell factor (SCF), and increase levels of tumor 
necrosis factor-alpha (TNF-alpha) and interleukin-1 (IL-1) (Lee AY, 2012).  
 
Genetic factors also have found to impact vitiligo. Epidemiologic studies in Caucasian families 
support that vitiligo is inherited in a non-Mendelian, multifactorial, polygenic pattern with 
incomplete penetrance (Alkhateeb A et al, 2003). Most cases of vitiligo are sporadic although 
familial clustering is not uncommonly seen.  
 
Currently, reversing vitiligo depigmentation treatments, such as phototherapy psoralen plus 
ultraviolet (PUVA) and Narrow band UVB (NB-UVB) irradiation, is the most common medical 
therapy available for vitiligo. UVB phototherapy refers to the use of artificial UVB radiation in the 
treatment of medical conditions without the addition of exogenous photosensitizers. The radiation 
absorbed by endogenous chromophores, and the photo-chemical reactions involving these 
biomolecules mediate a variety of biological pathways, ultimately leading to the therapeutic effects. 
The mechanism of action of NB-UVB is not fully clear although in vitro studies provide support 

 
 
 
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that phototherapy stimulates melanocyte migration and proliferation and exhibit immune-
modulating effects (Wu CS et al., 2007, Nishimura EK et al., 2002 and Chou WC et al., 2013). NB-
UVB has also shown to promote repigmentation by inducing tyrosinase, an enzyme involved in 
melanin production, and increasing the presentation of HMB-45 marker on the surface of 
melanosomes (De Francesco V et al, 2008). Goldstein B et al., 2015 observes that vitiligo skin that 
received NB-UVB treatment of 3-6 months bring depigmented skin to normal status with no 
difference in melanocyte marker expression between treated and normal skin. 
 
In addition, NV-UVB phototherapy is FDA-approved for both in-office and at-home treatment of 
vitiligo. The efficacy of NB-UVB phototherapy has been demonstrated in clinical studies, with 
heterogeneity among the trials with respect to disease severity, percent of body surface are affected, 
skin type, treatment, compliance, and outcome measures. In the 1997, Westerhof et al., first 
demonstrated that NB-UVB is effective in treating vitiligo. Most of the clinical studies on NB-UVB 
in vitiligo incorporated a comparator treatment group; rarely were there studies that compared NB-
UVB with placebo in the treatment of vitiligo. Nevertheless, NB-UVB was found to be effective as 
monotherapy for vitiligo lesions and essentially a non-drug treatment that can be administered to 
patients quickly and safely (Yashar et al, 2003; Natta et al, 2003; Hamzavi et al, 2004; Kanwar et al, 
2005; Parsad D et al, 2006; Bhatnagar et al, 2007; El-Zawahry BM et al, 2012). 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
b. Study duration and number of study visits required of research participants. 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
e. Justification for inclusion of a placebo or non-treatment group. 
f. Definition of treatment failure or participant removal criteria. 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
 
This is an investigator-initiated, single-blinded, localized ascending dose study of NB-UVB 
treatment for vitiligo in adults of 3 treatments for one week. It is designed to measure the 
molecular changes and repigmentation in affected and normal skin of participants with vitiligo 
and normal skin in healthy participants. The study will collect questionnaire information, patient 
and clinical evaluations, and skin biopsies from each participant.  
 
For all enrolled subjects, the starting dose will be 250 mJ/cm2, which is the standard of care for 
patients with vitiligo. The dose will be increased by 10% with each treatment, as long as there 
are no side effects with treatment such as burning or redness/ erythema. Skin biopsies will be 
collected from normal skin and from affected skin from vitiligo patients, and from normal skin 
of healthy patients at the baseline visit and up to 1 week after the conclusion of treatment; up to 
a total of 6 biopsies will be collected from each patient. Collected tissue samples will undergo 
subsequent pathological examination or laboratory analysis. Recording of the initial treatment 
dose and the 10% increase in dosing per visit is tracked. All data collection is secured and stored 
in locked office of our Cutaneous Translational Research Program (CTReP). 
 

 
 
 
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Recruitment: Individuals will be recruited from the patient population seen at the general 
dermatology clinics of Johns Hopkins Department of Dermatology or from the patient 
population participating in Johns Hopkins Cutaneous Translational Research Program (CTReP) 
research studies. Potential participants will also be recruited if they are referred by other 
providers. Patients referred from other providers will have been asked their interest in learning 
more about the study and will have given their permission to be contacted by a study team 
member for more information. Participants will also be recruited from other patient populations 
at the Johns Hopkins Hospital and/or surrounding community through the use of advertisements. 
Interested individuals will be interviewed either in-person or over the telephone to see whether 
they meet basic eligibility criteria to participate in the study (see inclusion/exclusion criteria). 
Once eligibility has been demonstrated, the potential subjects will be directed to make their 
study appointment with an investigator. 
 
Up to 20 healthy and vitiligo-diagnosed adult participants will be recruited. Interested, eligible 
participants will be invited to the initial visit, which will take place at the Cutaneous 
Translational Research Unit located at the Johns Hopkins Outpatient Center. At this 
appointment, to be conducted in a private exam room, the potential participant will be consented 
to participate in the study, for the collection of photographs, for administration of questionnaire, 
for an assessment of their skin, for phototherapy, and for skin biopsies. Prior to NB-UVB 
treatment, baseline biopsies will be obtained from normal and affected skin sites of vitiligo 
patients and normal skin of healthy patients. NB-UVB treatment will be administered on 
selected skin areas by research personnel. Patient will receive two additional NB-UVB 
treatments within the same week to total 3 treatments in a week, a typical schedule used in the 
treatment of vitiligo. Up to a week after the last treatment, biopsies will be obtained from treated 
skin regions. About 10 days after the biopsy, patient will return for suture removal. 
 
Questionnaire: A questionnaire on basic demographic information and past dermatologic 
history will be administered to subjects by CTReP investigators. Subjects will also be able to 
complete the questionnaire by themselves. Questionnaire data will be coded and stored on a 
secure hard drive managed by the CTReP staff. 
 
Device: The 3 Series PC & SP phototherapy cabinet is a microprocessor controlled full body 
fluorescent ultraviolet light source, with spectral output at peak wavelength of 311 nm (Narrow 
Band UVB). It is intended for use by or under the direction of a physician, for the treatment of 
psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the 
operator interface located on the front panel of the device. The 3 Series delivers full body 
phototherapy, whereby fluorescent tubes, which surround the patient, deliver the specified dose 
of UVB. 
 
Photographs: Digital photographs will be obtained by study staff of each participant, at skin 
regions of vitiligo and normal skin, such as the extremities and trunk that are receiving 
treatment and areas of biopsy. Photograph files will be stored on a secure hard drive in the 
CTReP. 
 
Skin biopsies: Up to six 4mm-punch biopsies will be performed at normal skin region and from 
treated vitiligo lesions for vitiligo patients or at normal skin for healthy patients: up to 3 biopsies 
will be obtained from each subject prior to NB-UVB treatment and up to 3 biopsies will be 
obtained up to one week after the last treatment. Biopsies will undergo subsequent pathological 
examination or laboratory analysis to assess for molecular change and repigmentation.  
The punch biopsy is a routine dermatological procedure consisting of local anesthesia with 1% 
lidocaine, followed by the punch which cuts a cylindrical core of epidermis, dermis, and 

 
 
 
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subcutaneous tissue. After removal of the tissue sample, a 4-0 suture is placed to close the 
circular opening on the arm (5-0 suture is used on the face). Ten days after the procedure, the 
sutures are removed. A 3-4 mm scar is formed, but typically blends well with the surrounding 
skin and becomes difficult to appreciate. 
 
Laboratory studies: Microscopic and/or immunohistochemical studies may be conducted on 
pathology slides obtained from biopsy specimens, and photographs of pathology slides may be 
taken. Biopsy specimens may also be molecularly evaluated for protein and gene expression. 
Remaining tissue material may be anonymously stored for use in future studies. Using collected 
skin biopsy samples, various biochemical markers of phototherapy-induced or other cellular 
characteristics may be studied.  Examples may include expression of melanocyte and 
keratinocyte markers, and migration of cells within the intra-epidermal and sub-epidermal 
regions.   
 
Objective Assessment/ Evaluation: Objective assessment of protein and gene expression will 
be conducted as above. The investigators performing the molecular testing will be blinded to the 
disease status and treatment status of the tissue. 
 
 
5. 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria  
• 
Adults 18 years or older with bilateral symmetrical vitiligo lesions, in general good health as 
determined by the Principal Investigator by medical history and physical exam. 
• 
Able to understand consent procedure 
• 
Able to comply with protocol activities 
 
 
Exclusion Criteria  
• 
Patients less than 18 years old 
• 
Patients not able to understand consent procedure 
• 
Patients unable to comply with protocol activities 
• 
Non-English speakers: the study assessments/questionnaires/evaluations are not 
scientifically validated in languages other than English. Given the lack of translators in over 50% 
of patient encounters in the dermatology clinic and the interpreters’ limited time commitments 
when one does show up, it is impossible to safely enroll or follow patients who do not speak 
English.  Phone translators are impossible given that we have written consent forms, which often 
exceed 10 pages in length. 
• 
Patients with a photosensitive disorder or on a medication which has been demonstrated in 
these patients to cause photosensitivity 
• 
Patients receiving concomitant phototherapy to test sites 
• 
Patient receiving topical medication to test sites within 2 weeks of study initiation  
• 
Patient receiving oral medications for vitiligo within 4 weeks prior to study initiation 
• 
Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to 
study initiation 
• 
Pregnant or nursing patients (self-reported) 
• 
Patient with significant medical history or concurrent illness that the investigator feels is not 
safe for study participation, including melanoma 
• 
Presence or suspicion of bleeding disorder or diathesis which would complicate biopsy. 
• 
Patients with history of excessive scar or keloid formation in the past 10 years 
• 
Patients with known allergy to anesthetic used 

 
 
 
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• 
Subjects with a pacemaker, implanted cardioverter-defibrillator, baroreflex activation 
device, cochlear implant, implanted bone growth stimulator, robotic limb prosthesis, subcutaneous 
GPS tracking device, electrodes implanted in the brain, attached electrodes in a subject undergoing 
cardiac defibrillation during the moment of skin color reading, or other device which may be 
disrupted by electrical current, UNLESS subject is kept “1 yard (one arm’s length) from the main 
unit” of the spectrophotometer at all times, as specified in device approval letter. 
 
 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
Device:  
The study device: 3 Series PC & SP Phototherapy Cabinet, marketed by Daavlin Distributing 
Company, will be used in this study. The device’s peak spectral output is Narrow Band UVB 
(NB-UVB): 311 nm.  FDA Device Listing Number: 21 CFR 878.4630. 
 
 
7. 
Study Statistics 
a. Primary outcome variable. 
b. Secondary outcome variables. 
c. Statistical plan including sample size justification and interim data analysis. 
d. Early stopping rules. 
 
Results from completed questionnaires may be analyzed using statistical tests such as the unpaired 
t-test or the Mann-Whitney/Wilcoxon rank sum non-parametric test. Images of biopsy samples will 
be processed using Adobe Photoshop CS3 software. Laboratory results will be analyzed at the JHU 
Department of Dermatology to compare the molecular changes associated with phototherapy 
treatment of vitiligo for up to one week. Data from the various age groups and skin-types will be 
compared using tests such as ANOVA followed by Bonferroni correction for multiple 
comparisons. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
b. Steps taken to minimize the risks. 
c. Plan for reporting unanticipated problems or study deviations. 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
e. Financial risks to the participants. 
 
Local Anesthesia 
The risk associated with local anesthesia (lidocaine with or without epinephrine) is very small and is 
mainly related to minor discomfort (typically an initial prick from the needle and then mild burning 
sensation from the medicine), possible bleeding, and a very small chance of infection or allergic 
reaction. 
 
Skin Biopsy 
During the biopsy, there should not be any pain, only pressure. There will likely be a small amount 
bleeding and, in very rare cases, infection at the site, and will result in a small linear scar (same 
length as the size of biopsy tool used) that typically heals without problem and fades over time.  
 
 
 
NB-UVB Phototherapy 
The reported side effects are: itching, burning, erythema, desquamation, transient 
hyperpigmentation, blistering, ulceration, and xerosis. There appears to be no increased risk for 
non-melanoma skin cancers or melanoma but all phototherapy modalities can induce photo-damage 
and photo-aging with prolonged use (Welsh O et al, 2009; Kanwar AJ et al, 2005; Chen GY et al, 
2005; Hearn RM et al, 2008). Mild side effects can be treated by the application of emollients such 
as petroleum jelly (Vaseline), while increased severity of side effects requires discontinuation of the 
treatment, application of emollients or the application of topical steroids. As with all phototherapy 
devices, exposure to UV light, whether it is from the sun or from a device requires eye protection. 
Protective eyewear will be available in the office and the treatment unit.  
 
Confidentiality 
In terms of confidentiality, there are minimal risks associated with breach of confidentiality. There 
is slight financial risk to the participants in the rare event that the above complications occur 
requiring additional medical care. 
 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
This study will be conducted in accordance with current U.S Food and Drug Administration (FDA) 
Good Clinical Practices (GCPs), and local ethical and legal requirements. 
 
Description of the probable benefits for the participant and for society:  
Individual participant: NB-UVB phototherapy have been shown to improve skin conditions like 
vitiligo, thus it is very possible that the device can improve the participant’s skin findings as well as 
quality of life. This, however, cannot be guaranteed and it is possible that there will be no direct 
benefit to any individual participant.  
Society: There is potential for the enhanced understanding of the therapeutic effects of NB-UVB 
phototherapy on the treatment of vitiligo and optimizing a proposed treatment regimen using this 
modality. 
 

 
 
 
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10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
Study participants will receive all treatments and frequent assessments by dermatologists free of 
charge but will receive a compensation of $30 for each biopsy.  
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
Study costs will be completely borne by the Johns Hopkins Department of Dermatology. 
 

 
 
 
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12. 
Reference 
 
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Harris JE, Harris TH, Weninger W, Wherry EJ, Hunter CA, Turka LA. A Mouse Model of Vitiligo with 
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Lang KS, Caroli CC, Muhm A, Wernet D, Moris A, Schittek B et al. HLA-A2 restricted, melanocyte-
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Dermatol 2009. 161: 134-9. 
 
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poorer quality of life and psychiatric morbidity in patients with different dermatological conditions. 
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