Combination of Topical Liposomal Amphotericin B and Glucantime in Comparison With Glucantime Alone For the Treatment of Anthroponotic Cutaneous Leishmaniasis (Acl) Caused By Leishmania Tropica: Study Protocol For A Randomized, Controlled Trial

Background and objectives: cutaneous leishmaniasis (cl) treatment is a challenging issue, although numerous modalities have been introduced as candidate treatment for cl yet only antimonial agents are commonly used to treat cl, a different form of amphotericin b is used to treat visceral form of leishmaniasis but the efficacy against cl is not high. there are a few reliable clinical trials on cl, the main reason is the nature of the disease which required a well design protocol to evaluate the efficacy of any candidate treatment against cl. in this study, a protocol was developed and used to evaluate a topical formulation of a nano-liposomal form of amphotericin b in addition to glucantime to treat cl caused by l. tropica. materials and methods: this study is a phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of topical nano-liposomal amphotericin b (sinaampholeish 0.4%) in combination with intralesional injections of meglumine antimoniate in the treatment of acl caused by l. tropica. overall, 130 patients, aged 12-60 years, with a diagnosis of acl caused by l. tropica are recruited and treated according to the protocol. results: a total of 130 patients with cl lesion will be recruited and double- blind randomly treated with received intralesional injections of glucantime weekly or glucantime plus sinaampholeish for 4 weeks. conclusion: the results of this study showed that the protocol works well and the treatment was tolerated by both groups of patients.