Title: Production of nanoliposomal amphotercin B topical gel as effective treatment for human Cutaneous Leishmaniasis (CL) disease
Abstract:
Human cutaneous leishmaniasis (CL) is the disease caused by Leishmania sp. parasite and it endemic in Iraq and other world countries. This study comprised 78 cases of suspected CL disease. Before treatment, 66 (84.6%) cases were positive and 12 (15.4%) cases were negative among the three treatment groups. The reduction in the percentage of cases with positive microscopical examination was more pronounced in the case of Pentostam (Sodium Stibogluconate) during the first three weeks, but Nanoliposomal amphotericin B 0.4 % becomes more effective as the percent of cases with positive microscopical examination decreases.
Using the Nested-PCR reaction, the molecular technique revealed 60 (76.9%) positive and 18 (23.1%) negative examples from 78 skin lesion samples. The best results were found with Nanoliposomal amphotercin B 0.4 % topical gel, followed by pentostam 3 (20%), and finally flagyl 3 (12%) injections, when nested PCR exams were compared between the three therapy groups during weeks of follow up.
The study found a highly significant difference in mean recovery time between treatment groups (p < 0.001). The mean recovery time for the Nanoliposomal amphotericin B 0.4 % group was 2.87 ±0.67 (1-4) weeks, which was the shortest time ever documented. The mean recovery time in the flagyl group was 5.08 ±1.55 (1-8) weeks, which was the longest duration ever documented. The pentostam group had a mean recovery time of 4.00 ±1.13 (2-6) weeks, which was comparable to nanoliposomal amphotericin B0.4 % and flagyl.
In comparison to flagyl and pentostam groups, there was a significant change (reduction) in lesion size (cm) in the Nanoliposomal amphotericin B 0.4% group; however, changes in mean size were equivalent in the majority of weeks of follow up (p > 0.05). Lesion sizes shrank after three and four weeks.
Keywords: Leishmaniasis, Human, Diagnostic methods, Kala-azar, PCR methods, Nanobiotechnology