Randomised controlled trial of topical corticosteroid and home-based narrowband UVB for active and limited vitiligo - results of the HI-Light Vitiligo trial

Thomas, K.S., Batchelor, J.M., Akram, P., Chalmers, J.R., Haines, RH, Meakin, G.D., Duley, L., Ravenscroft, J.C., Rogers, A., Sach, T.H., Santer, M., Tan, W., White, J., Whitton, M.E., Williams, H.C., Cheung, S.T., Hamad, H., Wright, A., Ingram, J.R. ORCID: https://orcid.org/0000-0002-5257-1142, Levell, N.J., Goulding, J.M.R., Makrygeorgou, A., Bewley, A., Ogboli, M., Stainforth, J., Ferguson, A., Laguda, B., Wahie, S., Ellis, R., Azad, J., Rajasekaran, A., Eleftheriadou, V. and Montgomery, A.A. 2021. 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 184 (5) , pp. 828-839. 10.1111/bjd.19592

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Abstract

Background Evidence for the effectiveness of vitiligo treatments is limited. Objectives To determine effectiveness of (a) hand‐held narrowband‐UVB (NB‐UVB) and (b) combination of potent topical corticosteroid (TCS) and NB‐UVB compared to TCS, for localised vitiligo. Methods Pragmatic, 3‐arm, placebo‐controlled RCT (9 months’ treatment; 12 months’ follow‐up). Adults and children, recruited from secondary care and community, aged ≥5 years with active vitiligo affecting <10% of skin, were randomised 1:1:1 to receive: TCS (mometasone furoate 0.1% ointment + dummy NB‐UVB); NB‐UVB (NB‐UVB + placebo TCS); or combination (TCS + NB‐UVB). TCS applied once daily on alternating weeks; NB‐UVB administered alternate days in escalating doses, adjusted for erythema. Primary outcome: treatment success at 9 months at target patch assessed using participant‐reported Vitiligo Noticeability Scale, with multiple imputation for missing data. Results 517 participants were randomised: TCS (n=173), NB‐UVB (n = 169), combination (n=175). Primary outcome data were available for 370 (72%) participants. Target patch treatment success was 17% (TCS), 22% (NB‐UVB) and 27% (combination). Combination treatment was superior to TCS: adjusted between group difference 10.9% (95% CI 1.0% to 20.9%; p= 0.032; NNT=10). NB‐UVB alone was not superior to TCS: adjusted between group difference 5.2% (95% CI ‐4.4% to 14.9%; p= 0.290; NNT=19). Participants using interventions >75% expected were more likely to achieve treatment success, but effects were lost once treatment stopped. Localised grade 3 or 4 erythema was reported in 62 (12%) participants (including 3 with dummy light). Skin thinning was reported in 13 (2.5%) participants (including 1 with placebo ointment). Conclusion Combination treatment with home‐based hand‐held NB‐UVB plus TCS is likely to be superior to TCS alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated but was only successful in around a quarter of participants.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Additional Information:	This is an open access article under the terms of the Creative Commons Attribution License
Publisher:	Wiley
ISSN:	0007-0963
Funders:	NIHR
Date of First Compliant Deposit:	3 October 2020
Date of Acceptance:	2 October 2020
Last Modified:	04 May 2023 12:12
URI:	https://orca.cardiff.ac.uk/id/eprint/135291

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