Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo

Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'
quality of life across all degrees of involvement and severity. Phototherapy is a clinically
indicated treatment for skin lesions. Treatments are usually administered in an outpatient
setting, typically three times per week. This is a proof-of-concept study as there are few
well-designed prospective clinical studies showing the efficacy of NB-UVB phototherapy in the
treatment of vitiligo in terms of repigmentation and quality of life. The following are the
proposed objectives of this study:

1. NB-UVB phototherapy improves vitiligo with at least 50% repigmentation compared to no
treatment on affected areas of the trunk and extremities over 24 weeks.

2. NB-UVB phototherapy leads to improvement in quality of life as measured by standardized
quality of life metrics (DLQI and Skindex-29) over 24 weeks.

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

- If a woman, before entry she must be:

1. postmenopausal, defined as 45 years of age with amenorrhea for at least 18
months, or >45 years of age with amenorrhea for at least 6 months and a serum
follicule stimulating hormone (FSH) level >40 IU/mL, or surgically postmenopausal
(bilateral oophorectomy), or

2. surgically sterile (have had a hysterectomy or tubal ligation or otherwise be
incapable of pregnancy), or

3. If heterosexually active and of childbearing potential, practicing a highly
effective method of birth control, (examples include hormonal prescription oral
contraceptives, contraceptive injections, contraceptive patch, intrauterine
device, double-barrier method (e.g. condoms, diaphragms, or cervical cap, with
spermicidal foam, cream, or gel), or male partner sterilization consistent with
local regulations regarding the use of birth control methods for subjects
participating in clinical trials, for the duration of their participation in the
study, or

4. Not heterosexually active

Exclusion Criteria:

- Patients less than 18 years old

- Patients not able to understand consent procedure

- Patients unable to comply with protocol activities

- Patients that do not have bilateral symmetrical vitiligo lesions

- 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

- Systemic corticosteroid therapy within the past month Concurrent use of drugs listed
in Appendix C.