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Abstract：
BACKGROUND: Current treatment options for Malassezia folliculitis (MF) are limited. Recent research has demonstrated the inhibitory effect of cold atmospheric plasma (CAP) on the growth of Malassezia pachydermatis in vitro, suggesting CAP as a potential therapeutic approach for managing MF.
OBJECTIVE: The objective of our study is to assess the in vitro antifungal susceptibility of Malassezia yeasts to CAP. Additionally, we aim to evaluate the efficacy and tolerability of CAP in treating patients with MF.
METHODS: We initially studied the antifungal effect of CAP on planktonic and biofilm forms of Malassezia yeasts, using well-established techniques such as zone of inhibition, transmission electron microscopy, colony count assay and 2,3-bis(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide salt assay. Subsequently, a randomized (1:1 ratio), active comparator-controlled, observer-blind study was conducted comparing daily CAP therapy versus itraconazole 200 mg/day for 2 weeks in 50 patients with MF. Efficacy outcomes were measured by success rate, negative microscopy rate and changes in Dermatology Life Quality Index (DLQI) and Global Aesthetic Improvement Scale (GAIS) scores. Safety was assessed by monitoring adverse events (AEs) and local tolerability.
RESULTS: In laboratory investigations, CAP time-dependently inhibited the growth of Malassezia yeasts in both planktonic and biofilm forms. Forty-nine patients completed the clinical study. At week 2, success was achieved by 40.0% of subjects in the CAP group versus 58.3% in the itraconazole group (p = 0.199). The negative direct microscopy rates of follicular samples were 56.0% in the CAP group versus 66.7% in the itraconazole group (p = 0.444). No significant differences were found in the proportion of subjects achieving DLQI scores of 0/1 (p = 0.456) or in the GAIS responder rates (p = 0.588) between the two groups. Three patients in the CAP group and one patient in the itraconazole group reported mild AEs.
CONCLUSIONS: CAP demonstrated significant antifungal activity against Malassezia yeasts in vitro and exhibited comparable efficacy to itraconazole in treating MF patients. Without the associated adverse effects of oral antifungal drugs, CAP can be considered a promising and safe treatment modality for MF.
OBJECTIVE: The objective of our study is to assess the in vitro antifungal susceptibility of Malassezia yeasts to CAP. Additionally, we aim to evaluate the efficacy and tolerability of CAP in treating patients with MF.
METHODS: We initially studied the antifungal effect of CAP on planktonic and biofilm forms of Malassezia yeasts, using well-established techniques such as zone of inhibition, transmission electron microscopy, colony count assay and 2,3-bis(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide salt assay. Subsequently, a randomized (1:1 ratio), active comparator-controlled, observer-blind study was conducted comparing daily CAP therapy versus itraconazole 200 mg/day for 2 weeks in 50 patients with MF. Efficacy outcomes were measured by success rate, negative microscopy rate and changes in Dermatology Life Quality Index (DLQI) and Global Aesthetic Improvement Scale (GAIS) scores. Safety was assessed by monitoring adverse events (AEs) and local tolerability.
RESULTS: In laboratory investigations, CAP time-dependently inhibited the growth of Malassezia yeasts in both planktonic and biofilm forms. Forty-nine patients completed the clinical study. At week 2, success was achieved by 40.0% of subjects in the CAP group versus 58.3% in the itraconazole group (p = 0.199). The negative direct microscopy rates of follicular samples were 56.0% in the CAP group versus 66.7% in the itraconazole group (p = 0.444). No significant differences were found in the proportion of subjects achieving DLQI scores of 0/1 (p = 0.456) or in the GAIS responder rates (p = 0.588) between the two groups. Three patients in the CAP group and one patient in the itraconazole group reported mild AEs.
CONCLUSIONS: CAP demonstrated significant antifungal activity against Malassezia yeasts in vitro and exhibited comparable efficacy to itraconazole in treating MF patients. Without the associated adverse effects of oral antifungal drugs, CAP can be considered a promising and safe treatment modality for MF.
摘要：
背景：目前对马拉色菌毛囊炎（MF）的治疗选择有限。最近的研究已经证明了冷大气等离子体（CAP）对体外生长的马拉色菌的抑制作用，建议CAP作为管理MF的潜在治疗方法。
目的：本研究的目的是评估马拉色菌对CAP的体外抗真菌敏感性。此外,我们的目的是评估CAP治疗MF患者的疗效和耐受性。
方法：我们最初研究了CAP对马拉色菌的浮游和生物膜形式的抗真菌作用，使用成熟的技术，如抑制区，透射电子显微镜,菌落计数测定和2,3-双(2-甲氧基-4-硝基-5-磺基苯基)-2H-四唑-5-甲酰苯胺盐测定。随后，随机（1：1比例），有源比较器控制，在50例MF患者中进行了观察者盲法研究,比较了每日CAP治疗与伊曲康唑200mg/天,持续2周.疗效结果以成功率衡量，显微镜阴性率和皮肤病生活质量指数（DLQI）和全球美学改善量表（GAIS）评分的变化。通过监测不良事件(AE)和局部耐受性来评估安全性。
结果：在实验室调查中，CAP时间依赖性地抑制浮游和生物膜形式的马拉色菌酵母的生长。49名患者完成了临床研究。在第2周，CAP组中40.0％的受试者成功，伊曲康唑组中58.3％（p=0.199）。CAP组卵泡样品的阴性直接镜检率为56.0％，伊曲康唑组为66.7％（p=0.444）。两组之间的DLQI得分达到0/1的受试者比例（p=0.456）或GAIS应答者比率（p=0.588）没有显着差异。CAP组中的3名患者和伊曲康唑组中的1名患者报告轻度AE。
结论：CAP在体外对马拉色菌酵母具有显著的抗真菌活性，在治疗MF患者中表现出与伊曲康唑相当的疗效。没有口服抗真菌药物的相关不良反应，CAP可以被认为是MF的一种有前途且安全的治疗方式。
目的：本研究的目的是评估马拉色菌对CAP的体外抗真菌敏感性。此外,我们的目的是评估CAP治疗MF患者的疗效和耐受性。
方法：我们最初研究了CAP对马拉色菌的浮游和生物膜形式的抗真菌作用，使用成熟的技术，如抑制区，透射电子显微镜,菌落计数测定和2,3-双(2-甲氧基-4-硝基-5-磺基苯基)-2H-四唑-5-甲酰苯胺盐测定。随后，随机（1：1比例），有源比较器控制，在50例MF患者中进行了观察者盲法研究,比较了每日CAP治疗与伊曲康唑200mg/天,持续2周.疗效结果以成功率衡量，显微镜阴性率和皮肤病生活质量指数（DLQI）和全球美学改善量表（GAIS）评分的变化。通过监测不良事件(AE)和局部耐受性来评估安全性。
结果：在实验室调查中，CAP时间依赖性地抑制浮游和生物膜形式的马拉色菌酵母的生长。49名患者完成了临床研究。在第2周，CAP组中40.0％的受试者成功，伊曲康唑组中58.3％（p=0.199）。CAP组卵泡样品的阴性直接镜检率为56.0％，伊曲康唑组为66.7％（p=0.444）。两组之间的DLQI得分达到0/1的受试者比例（p=0.456）或GAIS应答者比率（p=0.588）没有显着差异。CAP组中的3名患者和伊曲康唑组中的1名患者报告轻度AE。
结论：CAP在体外对马拉色菌酵母具有显著的抗真菌活性，在治疗MF患者中表现出与伊曲康唑相当的疗效。没有口服抗真菌药物的相关不良反应，CAP可以被认为是MF的一种有前途且安全的治疗方式。
