Department of Dermatology, Murshidabad Medical College and Hospital, Berhampore, West Bengal, India.
Department of Pharmacology, Rampurhat Government Medical College, Rampurhat, West Bengal, India.
Indian J Dermatol Venereol Leprol. 2019 May-Jun;85(3):276-281. doi: 10.4103/ijdvl.IJDVL_907_17.
Dermatophytosis is becoming increasingly unresponsive to conventional antifungals. Newer topical antifungals may be more effective in these patients.
To evaluate and compare the efficacy and safety of amorolfine 0.25% cream and sertaconazole 2% cream in limited tinea cruris/corporis.
A single-center, randomized (1:1), double-blind, parallel group, active-controlled trial (CTRI/2014/12/005246) was performed. Sixty-six untreated adults with acutely symptomatic tinea cruris/corporis were included in the study. All patients had limited cutaneous involvement and were KOH mount positive. Group A received amorolfine 0.25% cream, and group B received sertaconazole 2% cream twice daily application to the lesions for 4 weeks. After the baseline visit, four follow-up visits were carried out. The outcome measures for effectiveness were clinical and mycological cure. Safety parameters studied were treatment-emergent adverse events and changes in routine laboratory parameters.
Both sertaconazole and amorolfine significantly reduced symptoms (P < 0.001) in both groups. However, improvement in symptoms (pruritus, burning sensation, erythema, scaling and crusting) was significantly greater in the sertaconazole group at every follow-up visit. Sertaconazole cream was also more effective than amorolfine cream in reducing the number of lesions (P = 0.002 at 12 weeks) and improving the Dermatology Life Quality Index (P < 0.001) at all the follow-up visits. Adverse events were similar in the two groups (P = 0.117). Fungal cultures became negative in 92.3% of the sertaconazole group as compared to 80% in the amorolfine group (P = 0.010).
Antifungal susceptibility testing could not be done.
Sertaconazole 2% is superior to amorolfine 0.25%, both in terms of effectiveness and tolerability. Improvement can be appreciated from second week onwards.
皮肤癣菌病对抗真菌药物的反应越来越差。新型局部抗真菌药物可能对这些患者更有效。
评估并比较阿莫罗芬 0.25%乳膏和舍他康唑 2%乳膏治疗局限性体股癣的疗效和安全性。
采用单中心、随机（1:1）、双盲、平行组、阳性对照临床试验（CTRI/2014/12/005246）。纳入 66 例未经治疗的急性症状性体股癣成年患者。所有患者均有局限性皮肤受累，KOH 镜检阳性。A 组给予阿莫罗芬 0.25%乳膏，B 组给予舍他康唑 2%乳膏，每日两次涂于皮损处，疗程 4 周。基线访视后，进行 4 次随访。有效性的终点指标为临床和真菌学治愈。研究的安全性参数包括治疗中出现的不良事件和常规实验室参数的变化。
舍他康唑和阿莫罗芬均能显著改善两组患者的症状（P<0.001）。然而，在每个随访时间点，舍他康唑组的症状改善（瘙痒、烧灼感、红斑、鳞屑和结痂）均显著大于阿莫罗芬组。在第 12 周时，舍他康唑乳膏也更能有效减少皮损数量（P=0.002），在所有随访时间点改善皮肤病生活质量指数（P<0.001）。两组的不良事件相似（P=0.117）。与阿莫罗芬组（80%）相比，舍他康唑组的真菌培养转阴率更高（92.3%）（P=0.010）。
无法进行抗真菌药敏试验。
舍他康唑 2%乳膏在疗效和耐受性方面均优于阿莫罗芬 0.25%乳膏。从第二周开始即可观察到改善。
