The proposed study encompasses a two-step approach. The first aiming to determine the safety of Topical 3% Amphotericin B Cream when applied three or two times per day for 4 weeks in subjects with un-complicated Cutaneous leishmaniasis (CL) whilst the second focusing in having and indication of the efficacy of the two above mentioned regimens of Topical 3% Amphotericin B Cream For the first step, 30 subjects will be randomly assigned to receive direct observed treatment (DOT) with Topical 3% Amphotericin B Cream applied either three or two times per day for 4 weeks. Enrolment will be temporarily halted until all 30 subjects (15 in each group) have been enrolled and completed the 28 day treatment course. An interim analysis of all safety (Adverse Events, including local reactions and lab parameters) and pharmacokinetics collected on subjects who were randomized will be performed by data safety monitoring board. If no serious adverse events (SAEs) related to the study drug are identified on the first 30 subjects by the end of the treatment course, 50 additional subjects will be randomly allocated to receive Topical 3% Amphotericin B Cream either three or two times per day for 28 days Subjects will have a follow-up visit at the end of therapy, on Day 45± 5 days, Day 63± 5 days and on Days 90± 14 days and on Day 180, minus 14d, plus 4 weeks to assess efficacy, as measured by the number of subjects who fulfil the cure criteria: 100% re-epithelialization of the lesion(s) by Day 90 and no relapse by Day 180. All subjects will be followed up to Day 180 for final analysis of efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia
Medellín, Colombia
Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day.
Local adverse events including erythema/redness, swelling/oedema, and vesicles will be scored according the following criteria: Grade 1: Visibly present but not associated with any other symptoms. Grade 2: Visibly present, large area around lesion site, and associated with other symptoms such as itching or pain. Medical intervention may be required. Grade 3: Severe symptoms that require medical discontinuation of the study drug.
Time frame: At the end of treatment (Day 28)
Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day
Cure is defined as 100% re-epithelialization of the lesion(s) by Day 90.
Time frame: Day 90
Determination of Amphotericin B Cmax and Tmax in subjects treated with Anfoleish three or two times per day.
Time frame: Day 45
Proportion and severity of laboratory adverse events of Anfoleish or vehicle when applied three or two times per day
Laboratory adverse events are limited to monitoring serum levels of creatinine, alanine aminotransferase and aspartate aminotransferase.
Time frame: At the end of treatment (Day 28
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