Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo – results of the HI‐Light Vitiligo trial
Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo – results of the HI‐Light Vitiligo trial
Background: Evidence for the effectiveness of vitiligo treatments is limited. Objectives: To determine the effectiveness of (i) handheld narrowband UVB (NB-UVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB-UVB, compared with TCS alone, for localized vitiligo. Methods: A pragmatic, three-arm, placebo-controlled randomized controlled trial (9-month treatment, 12-month follow-up). Adults and children, recruited from secondary care and the community, aged ≥ 5 years and with active vitiligo affecting < 10% of skin, were randomized 1 : 1 : 1 to receive TCS (mometasone furoate 0·1% ointment + dummy NB-UVB), NB-UVB (NB-UVB + placebo TCS) or a combination (TCS + NB-UVB). TCS was applied once daily on alternating weeks; NB-UVB was administered on alternate days in escalating doses, adjusted for erythema. The primary outcome was treatment success at 9 months at a target patch assessed using the participant-reported Vitiligo Noticeability Scale, with multiple imputation for missing data. The trial was registered with number ISRCTN17160087 on 8 January 2015. Results: In total 517 participants were randomized to TCS (n = 173), NB-UVB (n = 169) and combination (n = 175). Primary outcome data were available for 370 (72%) participants. The proportions with target patch treatment success were 17% (TCS), 22% (NB-UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between-group difference 10·9% (95% confidence interval 1·0%–20·9%; P = 0·032; number needed to treat = 10). NB-UVB alone was not superior to TCS: adjusted between-group difference 5·2% (95% CI − 4·4% to 14·9%; P = 0·29; number needed to treat = 19). Participants using interventions with ≥ 75% expected adherence were more likely to achieve treatment success, but the effects were lost once treatment stopped. Localized grade 3 or 4 erythema was reported in 62 (12%) participants (including three with dummy light). Skin thinning was reported in 13 (2·5%) participants (including one with placebo ointment). Conclusions: Combination treatment with home-based handheld NB-UVB plus TCS is likely to be superior to TCS alone for treatment of localized vitiligo. Combination treatment was relatively safe and well tolerated but was successful in only around one-quarter of participants.
Thomas, K.S.
3eb8b4f5-2076-4edc-a7f5-30787773e1bf
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
UK Dermatology Clinical Trials Network’s HI-LIGHT Vitiligo Trial Team
Thomas, K.S.
3eb8b4f5-2076-4edc-a7f5-30787773e1bf
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
Thomas, K.S.
,
et al. and UK Dermatology Clinical Trials Network’s HI-LIGHT Vitiligo Trial Team
(2020)
Randomised controlled trial of topical corticosteroid and home‐based narrowband UVB for active and limited vitiligo – results of the HI‐Light Vitiligo trial.
British Journal of Dermatology.
(doi:10.1111/bjd.19592).
Abstract
Background: Evidence for the effectiveness of vitiligo treatments is limited. Objectives: To determine the effectiveness of (i) handheld narrowband UVB (NB-UVB) and (ii) a combination of potent topical corticosteroid (TCS) and NB-UVB, compared with TCS alone, for localized vitiligo. Methods: A pragmatic, three-arm, placebo-controlled randomized controlled trial (9-month treatment, 12-month follow-up). Adults and children, recruited from secondary care and the community, aged ≥ 5 years and with active vitiligo affecting < 10% of skin, were randomized 1 : 1 : 1 to receive TCS (mometasone furoate 0·1% ointment + dummy NB-UVB), NB-UVB (NB-UVB + placebo TCS) or a combination (TCS + NB-UVB). TCS was applied once daily on alternating weeks; NB-UVB was administered on alternate days in escalating doses, adjusted for erythema. The primary outcome was treatment success at 9 months at a target patch assessed using the participant-reported Vitiligo Noticeability Scale, with multiple imputation for missing data. The trial was registered with number ISRCTN17160087 on 8 January 2015. Results: In total 517 participants were randomized to TCS (n = 173), NB-UVB (n = 169) and combination (n = 175). Primary outcome data were available for 370 (72%) participants. The proportions with target patch treatment success were 17% (TCS), 22% (NB-UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between-group difference 10·9% (95% confidence interval 1·0%–20·9%; P = 0·032; number needed to treat = 10). NB-UVB alone was not superior to TCS: adjusted between-group difference 5·2% (95% CI − 4·4% to 14·9%; P = 0·29; number needed to treat = 19). Participants using interventions with ≥ 75% expected adherence were more likely to achieve treatment success, but the effects were lost once treatment stopped. Localized grade 3 or 4 erythema was reported in 62 (12%) participants (including three with dummy light). Skin thinning was reported in 13 (2·5%) participants (including one with placebo ointment). Conclusions: Combination treatment with home-based handheld NB-UVB plus TCS is likely to be superior to TCS alone for treatment of localized vitiligo. Combination treatment was relatively safe and well tolerated but was successful in only around one-quarter of participants.
Text
bjd.19592
- Accepted Manuscript
More information
Accepted/In Press date: 2 October 2020
e-pub ahead of print date: 2 October 2020
Additional Information:
Funding Information:
The authors would like to thank all those who supported and contributed to delivery of the HI‐Light Vitiligo Trial, including the NIHR Clinical Research Network for assistance in identifying recruitment sites and provision of research infrastructure and staff, and the UK Dermatology Clinical Trials Network (DCTN) for help in trial design and identifying recruiting sites. The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the network. We are grateful to Dermfix Ltd ( www.dermfix.uk ) for providing the NB‐UVB devices and dummy devices at a reduced cost. Dermfix Ltd had no role in the design, conduct or analysis of the trial. Members of the Centre of Evidence Based Dermatology’s Patient Panel provided input into the trial design and conduct and dissemination of trial findings. Thanks also to the people who responded to the online surveys to inform the trial design. A full list of contributors is provided in Appendix S1 (see Supporting Information).
Publisher Copyright:
© 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists
Identifiers
Local EPrints ID: 444623
URI: http://eprints.soton.ac.uk/id/eprint/444623
ISSN: 0007-0963
PURE UUID: a9c51d84-f4d8-4480-8b43-bd222bf02a44
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Date deposited: 27 Oct 2020 19:56
Last modified: 17 Mar 2024 06:00
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Author:
K.S. Thomas
Corporate Author: et al.
Corporate Author: UK Dermatology Clinical Trials Network’s HI-LIGHT Vitiligo Trial Team
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