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.
- randomised controlled trial
- topical corticosteroid
- combination therapy
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Contributors JB is the Chief Investigator and KST is lead investigator on the grant. HCW, VE, JCR, DW, AR, THS, MS, PA, JRC, LD, AAM, EJM and RHH contributed to the design of the study. GM and RHH are responsible for managing the trial from Nottingham CTU, with the help of JW. AAM, WT and TH are responsible for the statistical analysis plan. THS is the lead for the health economic component. RHH wrote the initial manuscript with KST and JB. All authors reviewed and approved the manuscript.
Funding This protocol paper summarises independent research funded by the National Institute for Health Research (NIHR) under its Health Technology Assessment Programme (project number 12/24/02). The pilot RCT was funded by the National Institute for Health Research (NIHR) under its programme grants for applied research (RP-PG-0407-10177). The HI-Light Vitiligo Trial purchased the devices from Dermfix at a discounted rate. Dermfix assisted in sourcing dummy devices for the trial and in arranging logistics of supply, but have had no input into the design or conduct of the trial. The UK Dermatology Clinical Trials Network receive infrastructure funding from the British Association of Dermatologists.
Disclaimer The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests HCW is Director of the NIHR Health Technology Assessment Programme. THS holds a Career Development Fellowship (NIHR-2014-07-006) supported by the National Institute for Health Research.
Patient consent Obtained.
Ethics approval Prior to the start of recruitment, appropriate approvals were granted by MHRA (EudraCT No. 2014-003473-42), NHS Health Research Authority, NRES Committee East Midlands—Derby (REC reference 14/EM/1173) and NHS Research & Development departments for each participating site.
Provenance and peer review Not commissioned; externally peer reviewed.
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