Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial
Introduction Keloids, benign fibroproliferative tumours characterised by excessive fibroblast proliferation and over-deposition of extracellular matrix, pose a therapeutic challenge with high recurrence rates. Betamethasone (diprospan) injection (BI) is one of the most common non-invasive therapies...
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crjcrbmj:10.1136/bmjopen-2024-084939 2024-09-30T14:42:45+00:00 Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial Wen, Junxian Li, Zhijin Liu, Weida Yu, Nanze Wang, Xiaojun National High Level Hospital 2024 http://dx.doi.org/10.1136/bmjopen-2024-084939 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2024-084939 en eng BMJ http://creativecommons.org/licenses/by-nc/4.0/ BMJ Open volume 14, issue 7, page e084939 ISSN 2044-6055 2044-6055 journal-article 2024 crjcrbmj https://doi.org/10.1136/bmjopen-2024-084939 2024-09-05T04:56:13Z Introduction Keloids, benign fibroproliferative tumours characterised by excessive fibroblast proliferation and over-deposition of extracellular matrix, pose a therapeutic challenge with high recurrence rates. Betamethasone (diprospan) injection (BI) is one of the most common non-invasive therapies for keloids. Pulsed dye laser (PDL) has the function of closing microvessels, which may become one of the auxiliary treatment methods of BI and may enhance its curative effect. Some studies suggest that the combination of a dual-wavelength dye laser (DWL) and BI may offer superior efficacy. This randomised controlled trial aims to evaluate whether the combined therapy of DWL+BI outperforms BI alone in treating keloids. Methods and analysis This single-centre, parallel positive control, randomised trial evaluates the efficacy and safety of DWL (585 nm PDL+1064 nm neodymium-doped yttrium aluminium garnet) combined with BI for keloid treatment. Enrolling 66 adult patients, participants are randomised into DWL+BI or BI groups in a 1:1 ratio. Over 12 weeks, each group undergoes four treatment sessions, ensuring blinding for outcome assessors. Data collection occurs at multiple time points (4, 12, 24 and 52 weeks), with primary outcomes assessing the Vancouver Scar Scale (VSS) improvement rate 24 weeks after the last intervention. Secondary outcomes include VSS improvement rates, changes in keloid volume, changes in relative perfusion index measured by laser speckle contrast imaging, Patient and Observer Scar Assessment Scale results and patient satisfaction. Safety assessments include vital signs, laboratory tests, pregnancy tests and self-reports of adverse reactions. Ethics and dissemination The results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Trial registration number Chinese Clinical Trial Register (ChiCTR2400080148). Article in Journal/Newspaper SCAR The BMJ BMJ Open 14 7 e084939 |
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Introduction Keloids, benign fibroproliferative tumours characterised by excessive fibroblast proliferation and over-deposition of extracellular matrix, pose a therapeutic challenge with high recurrence rates. Betamethasone (diprospan) injection (BI) is one of the most common non-invasive therapies for keloids. Pulsed dye laser (PDL) has the function of closing microvessels, which may become one of the auxiliary treatment methods of BI and may enhance its curative effect. Some studies suggest that the combination of a dual-wavelength dye laser (DWL) and BI may offer superior efficacy. This randomised controlled trial aims to evaluate whether the combined therapy of DWL+BI outperforms BI alone in treating keloids. Methods and analysis This single-centre, parallel positive control, randomised trial evaluates the efficacy and safety of DWL (585 nm PDL+1064 nm neodymium-doped yttrium aluminium garnet) combined with BI for keloid treatment. Enrolling 66 adult patients, participants are randomised into DWL+BI or BI groups in a 1:1 ratio. Over 12 weeks, each group undergoes four treatment sessions, ensuring blinding for outcome assessors. Data collection occurs at multiple time points (4, 12, 24 and 52 weeks), with primary outcomes assessing the Vancouver Scar Scale (VSS) improvement rate 24 weeks after the last intervention. Secondary outcomes include VSS improvement rates, changes in keloid volume, changes in relative perfusion index measured by laser speckle contrast imaging, Patient and Observer Scar Assessment Scale results and patient satisfaction. Safety assessments include vital signs, laboratory tests, pregnancy tests and self-reports of adverse reactions. Ethics and dissemination The results will be presented in peer-reviewed journals and at international conferences. This study is approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences. Trial registration number Chinese Clinical Trial Register (ChiCTR2400080148). |
author2 |
National High Level Hospital |
format |
Article in Journal/Newspaper |
author |
Wen, Junxian Li, Zhijin Liu, Weida Yu, Nanze Wang, Xiaojun |
spellingShingle |
Wen, Junxian Li, Zhijin Liu, Weida Yu, Nanze Wang, Xiaojun Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
author_facet |
Wen, Junxian Li, Zhijin Liu, Weida Yu, Nanze Wang, Xiaojun |
author_sort |
Wen, Junxian |
title |
Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
title_short |
Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
title_full |
Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
title_fullStr |
Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
title_full_unstemmed |
Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
title_sort |
dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial |
publisher |
BMJ |
publishDate |
2024 |
url |
http://dx.doi.org/10.1136/bmjopen-2024-084939 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2024-084939 |
genre |
SCAR |
genre_facet |
SCAR |
op_source |
BMJ Open volume 14, issue 7, page e084939 ISSN 2044-6055 2044-6055 |
op_rights |
http://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1136/bmjopen-2024-084939 |
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BMJ Open |
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14 |
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7 |
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e084939 |
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1811644629427159040 |