IP-TPT UMR MD3, Aix-Marseille Université, 13885, Marseille, France.
Mycopathologia. 2015 Apr;179(3-4):187-93. doi: 10.1007/s11046-014-9849-y. Epub 2014 Dec 17.
Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate.
This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis.
Males aged 6-15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily.
Five patients were treated with 1% squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly (p = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo.
This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis. Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis.
需要新的治疗头癣的方法，天然氨基固醇鲨烯胺是一种有潜力的局部抗真菌候选药物。
本项为期 3 周的随机双盲安慰剂对照临床试验旨在测试鲨烯软膏方案治疗头癣的疗效和安全性。
年龄在 6-15 岁之间的男性头癣患者接受外用鲨烯软膏或安慰剂治疗 3 周。主要终点是完全临床治愈。次要终点是局部和/或全身不良事件、真菌学治愈和部分临床反应。每日对临床不良事件进行前瞻性随访。
5 名患者接受 1%鲨烯软膏治疗，15 名患者接受安慰剂治疗。未观察到完全治愈。未记录到临床或生物学不良事件。与安慰剂组相比，接受鲨烯胺治疗的患者的毛发生长评分明显（p=0.03）更好，表明头癣病变的部分临床改善。
这种为期 3 周的鲨烯软膏方案耐受性良好，对头癣的治疗具有令人鼓舞的部分临床活性。需要进一步研究评估单独使用局部鲨烯胺或联合全身抗真菌药物对头癣或体癣的疗效。
