Recipient organisationUniversity of NottinghamSource-published name: The University of Nottingham
Funding£1.5M
PeriodNov 2014 — Jul 2019
In plain English
AI plain-English summary
A hand-held ultraviolet light device, used at home, could help children and adults regain skin colour lost to vitiligo. This trial tests whether combining narrow-band UVB light therapy with a potent steroid cream works better than either treatment alone. Vitiligo causes white patches on the skin, and existing treatments—light therapy in hospital clinics or steroid creams—are time-consuming, inconvenient, or have limited effectiveness. No high-quality trial has directly compared home-based light therapy, topical steroids, and their combination in people with less than 10% body surface area affected. The trial also addresses a priority identified by patients and clinicians through a James Lind Alliance partnership. If the combination therapy proves superior, patients could self-treat at home with a device that costs far less than repeated hospital visits. The trial includes a cost-effectiveness analysis from both NHS and family perspectives, so funders would know whether the approach is worth adopting. It also tracks whether repigmentation lasts for 12 months after treatment stops, answering a key question about durability. For the roughly 1% of the UK population with vitiligo, this could mean a practical, scalable treatment option that fits into daily life rather than requiring clinic appointments.
View original technical description
DESIGN: 3-arm, parallel group, double-blind RCT. Treatment will be for 9 months, with follow-up for a further 12 months after end of treatment (21 months in total). SETTING: Participants will be recruited in up to 16 UK hospitals. Treatment will be initiated in secondary care with self-treatment at home. Potential participants will be identified in secondary care, primary care and through direct advertising. TARGET POPULATION: Children (aged 5 years and over) and adults, with non-segmental vitiligo affecting less than 10% of body surface area, and at least one lesion that has appeared or has spread in the last 12 months. HEALTH TECHNOLOGIES: Hand-held narrow-band ultra-violet light therapy (NB-UVB) and potent topical corticosteroids will be compared with each other, and combination therapy will be compared to topical corticosteroids alone. Participants will be allocated to three groups: NB-UVB light therapy plus placebo ointment; placebo NB-UVB light therapy plus potent topical corticosteroid ointment; or NB-UVB light therapy plus potent topical corticosteroid ointment. MEASUREMENT OF COSTS & OUTCOMES: Primary outcome: Participant-reported treatment success at a target patch of vitiligo at 9 months (measured by how noticeable the vitiligo is compared to before treatment. Secondary outcomes: 1. Investigator-assessed onset of treatment response 2. Participant -reported treatment success for different body regions 3. Percentage repigmentation at 3, 6 and 9 months 4. Quality of life at end of treatment (9 months) and end of follow-up (21 months), using VitiQol, Skindex 29 and EQ-5D for adults, and CHU 9D for children 5. Time burden of treatment 6. Maintenance of gained repigmentation during follow-up phase Within trial cost-effectiveness analysis will also be conducted from an NHS perspective (primary) and a family perspective (secondary) SAMPLE SIZE: Assuming that 15% of participants allocated to receive topical corticosteroid (plus dummy light therapy) achieve treatment success as defined by the primary outcome, 372 participants are required to detect an absolute difference of 20%, with 2.5% two-sided alpha and 90% power. Allowing for 15% loss to follow-up, it was planned that a total of 440 participants would be recruited. Following a sample size review carried out by the Data Monitoring Committee in December 2016 the sample size was increased to 516 participants. PATIENT & PUBLIC INVOLVEMENT: This trial has been developed in response to a James Lind Alliance Priority Setting Partnership that identified this as an important topic for further research. The Priority Setting Partnership was also used to identify the most important outcome measures for use in vitiligo trials, and these results have been used to guide our choice of outcomes. A patient with vitiligo has been actively involved in the trial development group (as well as the Cochrane systematic review and pilot trial), and is a co-applicant on the grant. Feedback from participants in our pilot trial has been used to inform the data collection tools, training materials and choice of devices to be used. TIMETABLE: Based on our pilot RCT recruitment rates, we estimate that 3-5 participants will be randomised per centre per month. Duration of trial: 4 years 3 months. Approvals and set-up (6 months), recruitment (18 months), treatment (9 months), follow-up (12 months), analysis and write-up (6 months).
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