Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨

• Status: Completed
• Trial end date: 2019-09-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determine the efficacy and safety of a combined therapy using thermotherapy (TT) (one session, 50 degrees Celsius for 30") + miltefosine at a standard dose of 2.5 mg/kg/day for 21 days for the treatment of uncomplicated CL in Peru and Colombia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Treatments: Miltefosine

Criteria

Inclusion Criteria:

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 PCR, or 3) positive culture for promastigotes,

Patient has a lesion that satisfies the following criteria:

• Lesion size ≥ 0.5 cm and
• 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,

• Patient with
• Duration of lesion less than 4 months by patient history, Patient able to give written informed consent, In the opinion of the investigator, the patient is capable of understanding and complying with the protocol

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 trial 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 trial medication or exipients,

• Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to 6 months,

• Known history of drug addiction and/or alcohol abuse