K S Thomas1, J M Batchelor1, P Akram2, J R Chalmers1, R H Haines3, G D Meakin3, L Duley3, J C Ravenscroft4, A Rogers2, T H Sach5, M Santer6, W Tan3, J White3, M E Whitton1, H C Williams1, S T Cheung7, H Hamad7, A Wright8, J R Ingram9, N J Levell10, J M R Goulding11, A Makrygeorgou12, A Bewley13, M Ogboli14, J Stainforth15, A Ferguson16, B Laguda17, S Wahie18, R Ellis19, J Azad19, A Rajasekaran20, V Eleftheriadou21, A A Montgomery3. 1. Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK. 2. Department of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UK. 3. Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. 4. Department of Paediatric Dermatology, Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UK. 5. Norwich Medical School, University of East Anglia, Norwich, UK. 6. Primary Care and Population Sciences, University of Southampton, Southampton, UK. 7. Cannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UK. 8. St Luke's Hospital, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK. 9. Division of Infection and Immunity, Cardiff University, Cardiff, UK. 10. Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UK. 11. Solihull Hospital, University Hospitals of Birmingham NHS Foundation Trust, Birmingham, UK. 12. West Glasgow Ambulatory Care Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK. 13. Barts Health NHS Trust and Queen Mary University London, London, UK. 14. Birmingham Children's Hospital, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK. 15. York Hospital, York Teaching Hospital NHS Foundation Trust, York, UK. 16. Royal Derby Hospital and the London Road Community Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK. 17. Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK. 18. University Hospital of North Durham, County Durham and Darlington NHS Foundation Trust, Durham, UK. 19. The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK. 20. Birmingham City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. 21. Leicester Royal Infirmary, Leicester, UK.
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.
RCT Entities:
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.
Authors: Jonathan M Batchelor; Kim S Thomas; Perways Akram; Jaskiran Azad; Anthony Bewley; Joanne R Chalmers; Seau Tak Cheung; Lelia Duley; Viktoria Eleftheriadou; Robert Ellis; Adam Ferguson; Jonathan Mr Goulding; Rachel H Haines; Hamdi Hamad; John R Ingram; Bisola Laguda; Paul Leighton; Nick Levell; Areti Makrygeorgou; Garry D Meakin; Adam Millington; Malobi Ogboli; Amirtha Rajasekaran; Jane C Ravenscroft; Andrew Rogers; Tracey H Sach; Miriam Santer; Julia Stainforth; Wei Tan; Shyamal Wahie; Jennifer White; Maxine E Whitton; Hywel C Williams; Andrew Wright; Alan A Montgomery Journal: Health Technol Assess Date: 2020-11 Impact factor: 4.014
Authors: Paul Leighton; Joanne R Chalmers; Jonathan M Batchelor; Andy Rogers; Perways Akram; Rachel H Haines; Garry D Meakin; Jennifer White; Jane C Ravenscroft; Tracey H Sach; Miriam Santer; Maxine E Whitton; Viktoria Eleftheriadou; Kim S Thomas Journal: Clin Exp Dermatol Date: 2022-05-30 Impact factor: 4.481
Authors: N van Geel; L Depaepe; V Vandaele; L Mertens; J Van Causenbroeck; S De Schepper; L Van Coile; A Van Reempts; A-S De Vos; J Papeleu; I Hoorens; D Mertens; A Wolkerstorfer; J E Lommerts; R Speeckaert Journal: J Eur Acad Dermatol Venereol Date: 2022-04-29 Impact factor: 9.228