Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (SinaAmpholeish) on Healthy Volunteers: Phase I Clinical Trial
| Autor: | Akram Miramin Mohammadi, Mahmoud Reza Jaafari, Seyed Ebrahim Eskandari, Amir Javadi, Ali Khamesipour, Alireza Firooz, Mansour Nassiri-Kashani |
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| Rok vydání: | 2019 |
| Předmět: |
Nano-liposomal amphoter-icin B
Topical formulation 030231 tropical medicine Phases of clinical research lcsh:Infectious and parasitic diseases 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Forearm Amphotericin B Healthy volunteers Medicine lcsh:RC109-216 Adverse effect Cutaneous leishmaniasis business.industry Significant difference Discontinuation Skin reaction Infectious Diseases medicine.anatomical_structure Nano-liposomal amphotericin B Anesthesia Parasitology Original Article Safety business medicine.drug |
| Zdroj: | Iranian Journal of Parasitology Iranian Journal of Parasitology, Vol 14, Iss 2 (2019) Scopus-Elsevier |
| ISSN: | 1735-7020 |
| Popis: | Background: We aimed to evaluate the safety of SinaAmpholeish in a double-blind, randomized, phase 1 clinical trial in healthy human volunteers. Methods: 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 Leishmania 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. Results: 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. Conclusion: 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. |
| Databáze: | OpenAIRE |
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