None listed
Conditions
Interventions
Miltefosine: will be given orally at a dose of 2.5 mg/kg, daily, up to maximum total dose of 150 mg/day for 21 days.
Thermotherapy: One single session at 50°C for 30”. According to lesion size more
Sponsors
DRUGS FOR NEGLECTED DISEASE INITIATIVE,
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Males or females, aged ≥18 and ≤60 years old (Peru), • Subject 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 PCR, or 3) positive culture for promastigotes, • Subject 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, joints or on a location that in the opinion of the PI is difficult to apply TT, - Subject with <4 CL lesions, - Duration of lesion less than 4 months by patient history, • Subject able to give written informed consent, • In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
Exclusion criteria
Exclusion criteria: • Female with a positive urine pregnancy test at screening or who is breast feeding, lactating or female at fertile age who does not agree to take appropriate contraception during treatment period and up to D90, • History of clinically significant medical problems / treatment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition, • Within 8 weeks (56 days) of study Day 1, received treatment for leishmaniasis with any medication including antimonials likely, in the opinion of the PI, to modify the course of the Leishmania infection, • Has diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on physical exam, • History of known or suspected hypersensitivity or idiosyncratic reactions to study medication, • Patient who is not willing to attend the study visits, or is not able to comply with follow-up visits up to 6 months, • Known history of drug addiction and/or alcohol abuse.
Countries
Colombia, Peru
Contacts
Public ContactAlejandro Llanos
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed