Topical 3% Amphotericin B Cream for the Treatment of Cutaneous Leishmaniasis in Colombia
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
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.