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

Haines, Rachel H.; Thomas, Kim S.; Montgomery, Alan A.; Ravenscroft, Jane C.; Akram, Perways; Chalmers, J.R.; Whitman, Diane; Duley, Lelia; Eleftheriadou, Viktoria; Meakin, Garry; Mitchell, Eleanor; White, Jennifer; Rogers, Andy; Sach, Tracey; Santer, Miriam; Tan, Wei; Hepburn, Trish; Williams, Hywel C.; Batchelor, Jonathan M.

Abstract

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.

• Journal Article Type: Article
• Acceptance Date: Nov 7, 2017
• Publication Date: Apr 3, 2018
• Deposit Date: Nov 9, 2017
• Publicly Available Date: Apr 3, 2018
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 8
• Issue: 4
• Article Number: e018649
• DOI: https://doi.org/10.1136/bmjopen-2017-018649
• Keywords: Randomised controlled trial; Vitiligo; Topical corticosteroid; NB-UVB, combination therapy; Pragmatic
• Public URL: https://nottingham-repository.worktribe.com/output/923293
• Publisher URL: http://bmjopen.bmj.com/content/8/4/e018649