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

Stopped early · Not applicable

Conditions studied: Vitiligo, Pigmentation, Dyschromia

In brief

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

Key facts

Study ID

NCT02506101

Run by

Johns Hopkins University

People needed

2

Starts

2015-07-01

Expected to finish

2016-10-04

Last updated by the study team

2018-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• surgically sterile (have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy), or
• 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
• Not heterosexually active

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Dept. of Dermatology — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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