Abstract
Onychomycosis is a fungal infection of the nail. The aim of this randomized controlled clinical trial was to compare the efficacy of 2940-nm Er:YAG laser treatment combined with a 5% amorolfine lacquer versus amorolfine monotherapy for treating onychomycosis. In this study, patients with onychomycosis of the great toenail were randomly assigned to a combination therapy group and a monotherapy group. In the combination therapy group, the included toenails were treated with a fractional 2940-nm Er:YAG laser at weeks 1, 2, 3, 4, 8, and 12, combined with a 5% amorolfine lacquer twice a week for 12 weeks, while in the monotherapy group, the included toenails were treated with only a 5% amorolfine lacquer twice a week for 12 weeks. The onychomycosis severity index (OSI) score and the mycological clearance rate (MCR) of the included toenails were assessed at baseline, week 12, and week 24. At weeks 12 and 24, the great toenails with mild and moderate onychomycosis in the combination therapy group showed obvious improvement and a greater decrease in OSI than those in the monotherapy group. At week 24, the toenails with mild and moderate onychomycosis in the combination therapy group also showed a better MCR. For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24. In conclusion, fractional 2940-nm Er:YAG laser treatment combined with a 5% amorolfine lacquer is more effective than amorolfine monotherapy in short-term improvement of onychomycosis.
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This study was supported by the Sun Yat-sen Clinical Research Cultivating Program (SYS-Q-201705) from Sun Yat-sen Memorial Hospital.
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This study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (ethical number 2017018) and in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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The written informed consent approved by the Ethics Committee of Sun Yat-sen Memorial Hospital was obtained for all study participants prior to study participation.
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Zhang, J., Zhang, Y., Qin, J. et al. Comparison of a fractional 2940-nm Er:YAG laser and 5% amorolfine lacquer combination therapy versus a 5% amorolfine lacquer monotherapy for the treatment of onychomycosis: a randomized controlled trial. Lasers Med Sci 36, 147–152 (2021). https://doi.org/10.1007/s10103-020-03054-7
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DOI: https://doi.org/10.1007/s10103-020-03054-7