Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial
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 la...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group Ltd
2018
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| Online Access: | https://eprints.nottingham.ac.uk/48028/ |
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| author | 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. |
| author_facet | 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. |
| author_sort | Haines, Rachel H. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T20:07:39Z |
| format | Article |
| id | nottingham-48028 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T20:07:39Z |
| publishDate | 2018 |
| publisher | BMJ Publishing Group Ltd |
| recordtype | eprints |
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| spelling | nottingham-480282018-04-28T12:10:44Z https://eprints.nottingham.ac.uk/48028/ 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. 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. BMJ Publishing Group Ltd 2018-04-03 Article PeerReviewed application/pdf en cc_by https://eprints.nottingham.ac.uk/48028/9/Light%20e018649.full.pdf 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. and Batchelor, Jonathan M. (2018) Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial. BMJ Open, 8 (4). e018649/1-e018649/13. ISSN 2044-6055 Randomised controlled trial; Vitiligo; Topical corticosteroid; NB-UVB combination therapy; Pragmatic http://bmjopen.bmj.com/content/8/4/e018649 doi:10.1136/bmjopen-2017-018649 doi:10.1136/bmjopen-2017-018649 |
| spellingShingle | Randomised controlled trial; Vitiligo; Topical corticosteroid; NB-UVB combination therapy; Pragmatic 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. Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title | Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title_full | Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title_fullStr | Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title_full_unstemmed | Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title_short | Home interventions and light therapy for treatment of vitiligo (HI-Light Vitiligo Trial): study protocol for a randomized controlled trial |
| title_sort | home interventions and light therapy for treatment of vitiligo (hi-light vitiligo trial): study protocol for a randomized controlled trial |
| topic | Randomised controlled trial; Vitiligo; Topical corticosteroid; NB-UVB combination therapy; Pragmatic |
| url | https://eprints.nottingham.ac.uk/48028/ https://eprints.nottingham.ac.uk/48028/ https://eprints.nottingham.ac.uk/48028/ |