Eskandari Seyed Ebrahim, Firooz Alireza, Nassiri-Kashani Mansour, Jaafari Mahmoud Reza, Javadi Amir, Miramin Mohammadi Akram, Khamesipour Ali
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran.
Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Iran J Parasitol. 2019 Apr-Jun;14(2):197-203.
We aimed to evaluate the safety of SinaAmpholeish in a double-blind, randomized, phase 1 clinical trial in healthy human volunteers.
The study was carried out in DermaLab of Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran in 2012. A topical Nano-liposomal formulation of 0.4% Amphotericin B was developed against under trade name of SinaAmpholeish. In this randomized, double-blind, right-left, comparative, phase I clinical trial, in 2 steps; 7 and 20 healthy volunteers were recruited and applied SinaAmpholeish on the right and its vehicle on the left volar side of forearm, twice a day for one week or 3 times a day for two weeks. Seven biophysical skin parameters were measured in standard conditions before and 2 wk after application.
There was no adverse effect when SinaAmpholeish and its vehicle were used twice a day for seven days. However, when were used 3 times a day for two weeks, both SinaAmpholeish and its vehicle induced severe local skin reactions in 2 volunteers leading to discontinuation of application. Mild and temporary local reactions were observed in about half of the application sides and there was no significant difference between SinaAmpholeish and its vehicle.
The new formulation is safe and worth to be tested in further phase 2 clinical trial and since there was no adverse effect with twice a day application it was decided to use SinaAmpholeish twice a day in phase 2 clinical trial.
我们旨在通过一项针对健康人类志愿者的双盲、随机1期临床试验，评估SinaAmpholeish的安全性。
该研究于2012年在伊朗德黑兰医科大学皮肤病与麻风病研究与培训中心的皮肤实验室进行。研发了一种0.4%两性霉素B的纳米脂质体局部制剂，商品名为SinaAmpholeish。在这项随机、双盲、左右对照的1期临床试验中，分两步进行；招募了7名和20名健康志愿者，将SinaAmpholeish涂抹在前臂右侧，其赋形剂涂抹在左侧，每天两次，持续一周，或每天三次，持续两周。在涂抹前及涂抹后2周的标准条件下测量7项生物物理皮肤参数。
SinaAmpholeish及其赋形剂每天使用两次，持续7天时未出现不良反应。然而，当每天使用3次，持续两周时，SinaAmpholeish及其赋形剂均在2名志愿者中引起严重的局部皮肤反应，导致停药。在大约一半的涂抹部位观察到轻度和短暂的局部反应，SinaAmpholeish与其赋形剂之间无显著差异。
这种新制剂是安全的，值得在进一步的2期临床试验中进行测试，并且由于每天使用两次未出现不良反应，因此决定在2期临床试验中每天使用两次SinaAmpholeish。
