Mohamed Noha E, Rabie Doha F, Ahmed Fatma A, Abdelghani Rania, Yaseen Sara M
Dermatology and Venereology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.
Resident of Dermatology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.
Arch Dermatol Res. 2025 Feb 14;317(1):402. doi: 10.1007/s00403-025-03932-6.
Onychomycosis is a chronic fungal infection of the nails that accounts for10% of the population worldwide and about 50% of the nail diseases in clinical practice. It has negative impact on patient's quality of life. Multiple treatments are introduced to treat onychomycosis but they are limited by high cost, side effects, drug interaction, and reduced transungual delivery. We aimed to investigate the safety and efficacy of calcipotriol 0.005% cream versus terbinafine hydrochloride 1% cream in treatment of onychomycosis. Twenty adult patients with bilateral onychomycosis were randomized. Twenty adult patients with bilateral onychomycosis were randomized in this study. The patients received calcipotriol 0.005% cream on one side and terbinafine hydrochloride 1% cream on the other side twice/day for 3 months. Outcome was evaluated after treatment by onychomycosis severity index (OSI), mycological evaluation, investigator's assessment and patient's satisfaction. Side effects were also evaluated. Study registration number (IRB approval number M602, 30/8/2022). Calcipotriol 0.005% cream had significant higher degree of improvement after 3-month treatment of onychomycosis compared to terbinafine hydrochloride 1% cream (p value = 0.02), while calcipotriol had significantly higher side effects in terms of tolerable irritation compared to terbenafine (p value < 0.05). Insignificant differences between both sides were found regarding post treatment OSI, investigator's assessment and patient's satisfaction (p value = 0.12, 0.73, 0.22 respectively). This pilot study provided preliminary data for significant superiority of calcipotriol 0.005% cream in treatment of onychomycosis regarding degree of improvement after 3-month treatment compared to terbinafine hydrochloride 1% cream. Irritation induced by calcipotriol 0.005% cream was tolerable by the patients. Further studies are still needed.
甲癣是一种指甲的慢性真菌感染，全球10%的人口受其影响，在临床实践中约占指甲疾病的50%。它对患者的生活质量有负面影响。目前已采用多种治疗方法来治疗甲癣，但这些方法受到高成本、副作用、药物相互作用以及经甲递送减少的限制。我们旨在研究0.005%卡泊三醇乳膏与1%盐酸特比萘芬乳膏治疗甲癣的安全性和疗效。20例双侧甲癣成年患者被随机分组。本研究中，20例双侧甲癣成年患者被随机分组。患者一侧使用0.005%卡泊三醇乳膏，另一侧使用1%盐酸特比萘芬乳膏，每天两次，持续3个月。治疗后通过甲癣严重程度指数（OSI）、真菌学评估、研究者评估和患者满意度来评估结果。同时也评估了副作用。研究注册号（IRB批准号M602，2022年8月30日）。与1%盐酸特比萘芬乳膏相比，0.005%卡泊三醇乳膏治疗甲癣3个月后改善程度显著更高（p值 = 0.02），而与特比萘芬相比，卡泊三醇在可耐受刺激方面的副作用显著更高（p值 < 0.05）。在治疗后的OSI、研究者评估和患者满意度方面，两侧之间未发现显著差异（p值分别为0.12、0.73、0.22）。这项初步研究提供了初步数据，表明与1%盐酸特比萘芬乳膏相比，0.005%卡泊三醇乳膏在治疗甲癣3个月后的改善程度方面具有显著优势。0.005%卡泊三醇乳膏引起的刺激患者可以耐受。仍需要进一步研究。
