Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT
Background: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. Objective: To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compa...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
NIHR Journals Library
2020-11-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta24640 |
| _version_ | 1818735343408513024 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jonathan M Batchelor |
| collection | DOAJ |
| description | Background: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. Objective: To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compared with (1) hand-held narrowband ultraviolet B light monotherapy and (2) hand-held narrowband ultraviolet B light/topical corticosteroid combination treatment for localised vitiligo. Design: Pragmatic, three-arm, randomised controlled trial with 9 months of treatment and a 12-month follow-up. Setting: Sixteen UK hospitals – participants were recruited from primary and secondary care and the community. Participants: Adults and children (aged ≥ 5 years) with active non-segmental vitiligo affecting ≤ 10% of their body area. Interventions: Topical corticosteroids [mometasone furoate 0.1% (Elocon®, Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) plus dummy narrowband ultraviolet B light]; narrowband ultraviolet B light (narrowband ultraviolet B light plus placebo topical corticosteroids); or combination (topical corticosteroids plus narrowband ultraviolet B light). Topical corticosteroids were applied once daily on alternate weeks and narrowband ultraviolet B light was administered every other day in escalating doses, with a dose adjustment for erythema. All treatments were home based. Main outcome measures: The primary outcome was self-assessed treatment success for a chosen target patch after 9 months of treatment (‘a lot less noticeable’ or ‘no longer noticeable’ on the Vitiligo Noticeability Scale). Secondary outcomes included blinded assessment of primary outcome and percentage repigmentation, onset and maintenance of treatment response, quality of life, side effects, treatment burden and cost-effectiveness (cost per additional successful treatment). Results: In total, 517 participants were randomised (adults, n = 398; and children, n = 119; 52% male; 57% paler skin types I–III, 43% darker skin types IV–VI). At the end of 9 months of treatment, 370 (72%) participants provided primary outcome data. The median percentage of narrowband ultraviolet B light treatment-days (actual/allocated) was 81% for topical corticosteroids, 77% for narrowband ultraviolet B light and 74% for combination groups; and for ointment was 79% for topical corticosteroids, 83% for narrowband ultraviolet B light and 77% for combination. Target patch location was head and neck (31%), hands and feet (32%), and rest of the body (37%). Target patch treatment ‘success’ was 20 out of 119 (17%) for topical corticosteroids, 27 out of 123 (22%) for narrowband ultraviolet B light and 34 out of 128 (27%) for combination. Combination treatment was superior to topical corticosteroids (adjusted risk difference 10.9%, 95% confidence interval 1.0% to 20.9%; p = 0.032; number needed to treat = 10). Narrowband ultraviolet B light was not superior to topical corticosteroids (adjusted risk difference 5.2%, 95% confidence interval –4.4% to 14.9%; p = 0.290; number needed to treat = 19). The secondary outcomes supported the primary analysis. Quality of life did not differ between the groups. Participants who adhered to the interventions for > 75% of the expected treatment protocol were more likely to achieve treatment success. Over 40% of participants had lost treatment response after 1 year with no treatment. Grade 3 or 4 erythema was experienced by 62 participants (12%) (three of whom were using the dummy) and transient skin thinning by 13 participants (2.5%) (two of whom were using the placebo). We observed no serious adverse treatment effects. For combination treatment compared with topical corticosteroids, the unadjusted incremental cost-effectiveness ratio was £2328.56 (adjusted £1932) per additional successful treatment (from an NHS perspective). Limitations: Relatively high loss to follow-up limits the interpretation of the trial findings, especially during the post-intervention follow-up phase. Conclusion: Hand-held narrowband ultraviolet B light plus topical corticosteroid combination treatment is superior to topical corticosteroids alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated, but was effective in around one-quarter of participants only. Whether or not combination treatment is cost-effective depends on how much decision-makers are willing to pay for the benefits observed. Future work: Development and testing of new vitiligo treatments with a greater treatment response and longer-lasting effects are needed. Trial registration: Current Controlled Trials ISRCTN17160087. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 64. See the NIHR Journals Library website for further project information. |
| first_indexed | 2024-12-18T00:19:45Z |
| format | Article |
| id | doaj.art-7db2da641d1745c4a54809f9edb570f8 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-18T00:19:45Z |
| publishDate | 2020-11-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-7db2da641d1745c4a54809f9edb570f82022-12-21T21:27:22ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242020-11-01246410.3310/hta2464012/24/02Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCTJonathan M Batchelor0Kim S Thomas1Perways Akram2Jaskiran Azad3Anthony Bewley4Joanne R Chalmers5Seau Tak Cheung6Lelia Duley7Viktoria Eleftheriadou8Robert Ellis9Adam Ferguson10Jonathan MR Goulding11Rachel H Haines12Hamdi Hamad13John R Ingram14Bisola Laguda15Paul Leighton16Nick Levell17Areti Makrygeorgou18Garry D Meakin19Adam Millington20Malobi Ogboli21Amirtha Rajasekaran22Jane C Ravenscroft23Andrew Rogers24Tracey H Sach25Miriam Santer26Julia Stainforth27Wei Tan28Shyamal Wahie29Jennifer White30Maxine E Whitton31Hywel C Williams32Andrew Wright33Alan A Montgomery34Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKDepartment of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UKThe James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UKWhipps Cross Hospital and The Royal London Hospital, Barts Health NHS Trust, London, UKCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKBlackheath Hospital, Winchester House, London, UKNottingham Clinical Trials Unit, Nottingham, UKLeicester Royal Infirmary, Leicester, UKYork Hospital, York Teaching Hospital NHS Foundation Trust, York, UKRoyal Derby Hospital and the London Road Community Hospital, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UKSolihull Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UKNottingham Clinical Trials Unit, Nottingham, UKCannock Chase Hospital and New Cross Hospital, The Royal Wolverhampton NHS Trust, Wolverhampton, UKDivision of Infection and Immunity, Cardiff University, Cardiff, UKChelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UKCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKNorfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, UKWest Glasgow Ambulatory Care Hospital, NHS Greater Glasgow and Clyde, Glasgow, UKNottingham Clinical Trials Unit, Nottingham, UKPharmacy Production Unit, Nottingham University Hospitals NHS Trust, Nottingham, UKBirmingham Children’s Hospital, Birmingham Children’s Hospital NHS Foundation Trust, Birmingham, UKBirmingham City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UKDepartment of Paediatric Dermatology, Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust, Nottingham, UKDepartment of Medical Physics and Clinical Engineering, Nottingham University Hospitals NHS Trust, Nottingham, UKNorwich Medical School, University of East Anglia, Norwich, UKBlackheath Hospital, Winchester House, London, UKYork Hospital, York Teaching Hospital NHS Foundation Trust, York, UKNottingham Clinical Trials Unit, Nottingham, UKUniversity Hospital of North Durham; County Durham and Darlington NHS Foundation Trust, Durham, UKNottingham Clinical Trials Unit, Nottingham, UKCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKCentre of Evidence Based Dermatology, University of Nottingham, Nottingham, UKSt Luke’s Hospital, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UKNottingham Clinical Trials Unit, Nottingham, UKBackground: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. Objective: To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compared with (1) hand-held narrowband ultraviolet B light monotherapy and (2) hand-held narrowband ultraviolet B light/topical corticosteroid combination treatment for localised vitiligo. Design: Pragmatic, three-arm, randomised controlled trial with 9 months of treatment and a 12-month follow-up. Setting: Sixteen UK hospitals – participants were recruited from primary and secondary care and the community. Participants: Adults and children (aged ≥ 5 years) with active non-segmental vitiligo affecting ≤ 10% of their body area. Interventions: Topical corticosteroids [mometasone furoate 0.1% (Elocon®, Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) plus dummy narrowband ultraviolet B light]; narrowband ultraviolet B light (narrowband ultraviolet B light plus placebo topical corticosteroids); or combination (topical corticosteroids plus narrowband ultraviolet B light). Topical corticosteroids were applied once daily on alternate weeks and narrowband ultraviolet B light was administered every other day in escalating doses, with a dose adjustment for erythema. All treatments were home based. Main outcome measures: The primary outcome was self-assessed treatment success for a chosen target patch after 9 months of treatment (‘a lot less noticeable’ or ‘no longer noticeable’ on the Vitiligo Noticeability Scale). Secondary outcomes included blinded assessment of primary outcome and percentage repigmentation, onset and maintenance of treatment response, quality of life, side effects, treatment burden and cost-effectiveness (cost per additional successful treatment). Results: In total, 517 participants were randomised (adults, n = 398; and children, n = 119; 52% male; 57% paler skin types I–III, 43% darker skin types IV–VI). At the end of 9 months of treatment, 370 (72%) participants provided primary outcome data. The median percentage of narrowband ultraviolet B light treatment-days (actual/allocated) was 81% for topical corticosteroids, 77% for narrowband ultraviolet B light and 74% for combination groups; and for ointment was 79% for topical corticosteroids, 83% for narrowband ultraviolet B light and 77% for combination. Target patch location was head and neck (31%), hands and feet (32%), and rest of the body (37%). Target patch treatment ‘success’ was 20 out of 119 (17%) for topical corticosteroids, 27 out of 123 (22%) for narrowband ultraviolet B light and 34 out of 128 (27%) for combination. Combination treatment was superior to topical corticosteroids (adjusted risk difference 10.9%, 95% confidence interval 1.0% to 20.9%; p = 0.032; number needed to treat = 10). Narrowband ultraviolet B light was not superior to topical corticosteroids (adjusted risk difference 5.2%, 95% confidence interval –4.4% to 14.9%; p = 0.290; number needed to treat = 19). The secondary outcomes supported the primary analysis. Quality of life did not differ between the groups. Participants who adhered to the interventions for > 75% of the expected treatment protocol were more likely to achieve treatment success. Over 40% of participants had lost treatment response after 1 year with no treatment. Grade 3 or 4 erythema was experienced by 62 participants (12%) (three of whom were using the dummy) and transient skin thinning by 13 participants (2.5%) (two of whom were using the placebo). We observed no serious adverse treatment effects. For combination treatment compared with topical corticosteroids, the unadjusted incremental cost-effectiveness ratio was £2328.56 (adjusted £1932) per additional successful treatment (from an NHS perspective). Limitations: Relatively high loss to follow-up limits the interpretation of the trial findings, especially during the post-intervention follow-up phase. Conclusion: Hand-held narrowband ultraviolet B light plus topical corticosteroid combination treatment is superior to topical corticosteroids alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated, but was effective in around one-quarter of participants only. Whether or not combination treatment is cost-effective depends on how much decision-makers are willing to pay for the benefits observed. Future work: Development and testing of new vitiligo treatments with a greater treatment response and longer-lasting effects are needed. Trial registration: Current Controlled Trials ISRCTN17160087. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 64. See the NIHR Journals Library website for further project information.https://doi.org/10.3310/hta24640vitiligotopical corticosteroidhypopigmentationultraviolet therapydermatological agentsskincost-benefit analysisphototherapyoutcome assessment (health care)randomised controlled trials |
| spellingShingle | 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 Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT Health Technology Assessment vitiligo topical corticosteroid hypopigmentation ultraviolet therapy dermatological agents skin cost-benefit analysis phototherapy outcome assessment (health care) randomised controlled trials |
| title | Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT |
| title_full | Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT |
| title_fullStr | Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT |
| title_full_unstemmed | Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT |
| title_short | Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT |
| title_sort | home based narrowband uvb topical corticosteroid or combination for children and adults with vitiligo hi light vitiligo three arm rct |
| topic | vitiligo topical corticosteroid hypopigmentation ultraviolet therapy dermatological agents skin cost-benefit analysis phototherapy outcome assessment (health care) randomised controlled trials |
| url | https://doi.org/10.3310/hta24640 |
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