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

Johns Hopkins University

Status

Terminated

Conditions

Dyschromia

Vitiligo

Pigmentation

Treatments

Device: narrow-band ultraviolet B phototherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02506101

IRB00052103

Details and patient eligibility

About

The objective of this study is to assess the effectiveness and safety of narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.

Full description

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:

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.
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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.