e-ISSN: Pending
Negative / Null Result ReportOpen accessInfectious and parasitic diseases

Safety Evaluation of Topical Application of Nano-Liposomal Form of Amphotericin B (SinaAmpholeish) on Healthy Volunteers: Phase I Clinical Trial

Seyed Ebrahim ESKANDARI; Alireza FIROOZ; Mansour NASSIRI-KASHANI; Mahmoud Reza JAAFARI; Amir JAVADI; Akram MIRAMIN MOHAMMADI; Ali KHAMESIPOUR · 2019 · Iranian Journal of Parasitology

WASTE classifies this as Negative / Null Result Report · AI classification, approximate

The study found no significant effect — useful as a negative control or null benchmark for your own design.

Abstract

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 Si

Abstract by Seyed Ebrahim ESKANDARI; Alireza FIROOZ; Mansour NASSIRI-KASHANI; Mahmoud Reza JAAFARI; Amir JAVADI; Akram MIRAMIN MOHAMMADI; Ali KHAMESIPOUR, Iranian Journal of Parasitology (2019) — licensed CC BY 4.0.

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Metadata source: DOAJ · DOI 10.18502/ijpa.v14i2.1130