Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial

Haines, Rachel H. and Thomas, Kim S. and Montgomery, Alan A. and Ravenscroft, Jane C. and Akram, Perways and Chalmers, Joanne R. and Whitman, Diane and Duley, Lelia and Eleftheriadou, Viktoria and Meakin, Garry and Mitchell, Eleanor and White, Jennifer and Rogers, Andy and Sach, Tracey and Santer, Miriam and Tan, Wei and Hepburn, Trish and Williams, Hywel C. and Batchelor, Jonathan M. (2017) Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial. BMJ Open . ISSN 2044-6055 (In Press)

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Abstract

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 multi-centre, 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 8th January 2015 ISRCTN (17160087). Results will be published in full as open access in the NIHR Journal library and elsewhere.

Item Type: Article
Keywords: Randomised controlled trial; Vitiligo; Topical corticosteroid; NB-UVB, combination therapy; Pragmatic
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Division of Rheumatology, Orthopaedics and Dermatology
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Depositing User: Eprints, Support
Date Deposited: 09 Nov 2017 14:40
Last Modified: 11 Nov 2017 05:09
URI: http://eprints.nottingham.ac.uk/id/eprint/48028

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