This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line treatments comprising meglumine antimoniate for 3 weeks for the treatment of uncomplicated cutaneous leishmaniasis cases in the New World.
Who can participate
Age range12 Years – 60 Years
SexALL
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Inclusion Criteria:
* Males and females, aged ≥12 and ≤60 years old (upper age limit according to local regulations), and weighing ≥ 30Kg.
* Patient with a confirmed diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) demonstration of Leishmania by Polymerase Chain Reaction (PCR), or 3) positive culture for promastigotes.
* Patient has a lesion that satisfies the following criteria:
* Lesion size ≥ 0.5 cm and ≤ 4 cm (longest diameter).
* not located on the ear, face, close to mucosal membranes, or on a location that in the opinion of the Principal Investigator (PI) is difficult to apply the TT.
* Patient with ≤ 4 CL lesions.
* Duration of lesion less than 4 months by patient history.
* Patient able to give written informed consent/ assent form.
* In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
Exclusion Criteria:
* Female with a positive urine or blood pregnancy test at screening or who is breast feeding or female at fertile age who does not agree to take appropriate effective contraception during treatment period and up to D180 visit. In Brazil: female at fertile age who does not agree to use two effective methods of contraception: one barrier method and one highly effective method (defined in section 8.2.4) 30 days prior to the treatment onset and up to D180 visit.
* History of clinically significa…
What they're measuring
1
The proportion of initial clinical cure in each arm.