Introduction
Vitiligo is a condition resulting in white patches on the skin.
People with vitiligo can suffer from low self-esteem, psychological
disturbance and diminished quality of life. Vitiligo is often poorly
managed, partly due to lack of high-quality evidence to inform clinical
care. We describe here a large, independent, randomised controlled trial
(RCT) assessing the comparative effectiveness of potent topical
corticosteroid, home-based hand-held narrowband ultraviolet B-light
(NB-UVB) or combination of the two, for the management of
vitiligo.
Methods and analysis
The HI-Light Vitiligo Trial is a multicentre, three-arm, parallel
group, pragmatic, placebo-controlled RCT. 516 adults and children with
actively spreading, but limited, vitiligo are randomised (1:1:1) to one
of three groups: mometasone furoate 0.1% ointment plus dummy NB-UVB
light, vehicle ointment plus NB-UVB light or mometasone furoate 0.1%
ointment plus NB-UVB light. Treatment of up to three patches of vitiligo
is continued for up to 9 months with clinic visits at baseline, 3, 6 and
9 months and four post-treatment questionnaires.
The HI-Light Vitiligo Trial assesses outcomes included in the
vitiligo core outcome set and places emphasis on participants’ views of
treatment success. The primary outcome is proportion of participants
achieving treatment success (patient-rated Vitiligo Noticeability Scale)
for a target patch of vitiligo at 9 months with further independent
blinded assessment using digital images of the target lesion before and
after treatment. Secondary outcomes include time to onset of treatment
response, treatment success by body region, percentage repigmentation,
quality of life, time-burden of treatment, maintenance of response,
safety and within-trial cost-effectiveness.
Ethics and dissemination
Approvals were granted by East Midlands—Derby Research Ethics
Committee (14/EM/1173) and the MHRA (EudraCT 2014-003473-42). The trial
was registered 8 January 2015 ISRCTN (17160087). Results will be
published in full as open access in the NIHR Journal library and
elsewhere.
Trial registration number
ISRCTN17160087.