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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
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 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.

0007-0963
Thomas, K.S.
3eb8b4f5-2076-4edc-a7f5-30787773e1bf
Santer, Miriam
3ce7e832-31eb-4d27-9876-3a1cd7f381dc
et al.
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).

Record type: Article

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.

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bjd.19592 - Accepted Manuscript
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More information

Accepted/In Press date: 2 October 2020
e-pub ahead of print date: 2 October 2020

Identifiers

Local EPrints ID: 444623
URI: http://eprints.soton.ac.uk/id/eprint/444623
ISSN: 0007-0963
PURE UUID: a9c51d84-f4d8-4480-8b43-bd222bf02a44
ORCID for Miriam Santer: ORCID iD orcid.org/0000-0001-7264-5260

Catalogue record

Date deposited: 27 Oct 2020 19:56
Last modified: 09 Jan 2022 05:29

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Contributors

Author: K.S. Thomas
Author: Miriam Santer ORCID iD
Corporate Author: et al.
Corporate Author: UK Dermatology Clinical Trials Network’s HI-LIGHT Vitiligo Trial Team

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