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

Home interventions and light therapy for the treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomised controlled trial
Home interventions and light therapy for the treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomised controlled trial
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.
2044-6055
Haines, Rachel
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Thomas, Kim
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Montgomery, Alan
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Ravenscroft, Jane
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Akram, Perways
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Chalmers, Joanne
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Whitham, Diane
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Duley, Lelia
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Eleftheriadou, Viktoria
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Meakin, Garry
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Mitchell, Eleanor
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White, Jennifer
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Rogers, Andy
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Sach, Tracey
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Santer, Miriam
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Tan, Wei
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Hepburn, Trish
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Williams, Hywel
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Batchelor, Jonathan
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Haines, Rachel
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Thomas, Kim
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Montgomery, Alan
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Ravenscroft, Jane
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Akram, Perways
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Chalmers, Joanne
f41b7630-e3d1-488b-a633-be6ee711f84d
Whitham, Diane
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Duley, Lelia
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Eleftheriadou, Viktoria
3921e554-2fda-4415-b493-d7e64ba6d64c
Meakin, Garry
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Mitchell, Eleanor
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White, Jennifer
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Rogers, Andy
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Sach, Tracey
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Santer, Miriam
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Tan, Wei
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Hepburn, Trish
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Williams, Hywel
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Batchelor, Jonathan
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Haines, Rachel, Thomas, Kim, Montgomery, Alan, Ravenscroft, Jane, Akram, Perways, Chalmers, Joanne, Whitham, Diane, Duley, Lelia, Eleftheriadou, Viktoria, Meakin, Garry, Mitchell, Eleanor, White, Jennifer, Rogers, Andy, Sach, Tracey, Santer, Miriam, Tan, Wei, Hepburn, Trish, Williams, Hywel and Batchelor, Jonathan (2018) Home interventions and light therapy for the treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomised controlled trial. BMJ Open, 8 (4). (doi:10.1136/bmjopen-2017-018649).

Record type: Article

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 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.

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Accepted/In Press date: 7 November 2017
e-pub ahead of print date: 3 April 2018

Identifiers

Local EPrints ID: 420554
URI: http://eprints.soton.ac.uk/id/eprint/420554
ISSN: 2044-6055
PURE UUID: 7d680eb2-8437-4b61-9e09-efc2d48a68ea
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260

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Date deposited: 10 May 2018 16:30
Last modified: 17 Dec 2019 01:42

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Contributors

Author: Rachel Haines
Author: Kim Thomas
Author: Alan Montgomery
Author: Jane Ravenscroft
Author: Perways Akram
Author: Joanne Chalmers
Author: Diane Whitham
Author: Lelia Duley
Author: Viktoria Eleftheriadou
Author: Garry Meakin
Author: Eleanor Mitchell
Author: Jennifer White
Author: Andy Rogers
Author: Tracey Sach
Author: Miriam Santer ORCID iD
Author: Wei Tan
Author: Trish Hepburn
Author: Hywel Williams
Author: Jonathan Batchelor

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