NCT02687971

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

A Randomized, Open Label, Multicenter Study to Determine the Efficacy and Safety of Combining Thermotherapy and a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

The use of topical treatments for Cutaneous leishmaniasis (CL) is an option that has been widely explored and it is currently listed as an options by WHO in those situations where the patient has few lesions (≤ 4) of less than ≤ 4 cm in diameter and located in areas of the body which may be treated topically. Local heat, especially the one produced by radio frequency waves (Themo-Med®) has been widely tested for CL in both Old and New World. The advantages of using thermotherapy include: 1) high security profile; 2) only one session is required which ensures compliance with treatment; 3) easy to use in the field since the machine operates with batteries; 4) its effectiveness does not depend on the species of Leishmania causing the lesion as it is a physical measure; and 5) it can be used in patients in whom systemic treatment with antimonials are contraindicated, including women who are pregnant or breastfeeding. In the New World, Thermo-Med® has been evaluated in Mexico, Guatemala, Colombia and Brazil (all but one were randomized clinical trials), reporting cure rates of 90%, 73%, 64% and 75% respectively There are no clinical trials evaluating the efficacy of miltefosine for CL when given for less than 20 days. The 21-day course was chosen to give the best chances to the combination approach and based on a) the results of a Phase II trial conducted in Colombia showing that a mean dose of miltefosine of 133 mg/day/20 days resulted in a cure rate of 82%20 and; b) a report showing that the a daily administration of 100 mg/day (2.5 mg/kg of body weight/day for 28 days) resulted in a mean maximum concentration of drug in serum at day 23 of treatment of 70,000 ng/ml21. The theoretical advantages offered by this combination are that a) we are using two approaches that are currently recommended for use individually and for which there is good information regarding their efficacy and safety when used alone; b) the use of a topical plus a systemic treatment would hypothetically have an additive effect, since systemic treatment would eliminate those circulating or remaining parasites located in the periphery of the lesion that topical treatment fails to remove and which might be the cause of relapses22,23; c) it offers the opportunity to increase the current cure rate reported with any other treatment approach available when used alone; d) it will reduce the length of treatment with miltefosine and hopefully the cost and rates of adverse events associated with 28 days of treatment with miltefosine.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
DRUG	Miltefosine	Miltefosine (hexadecylphosphocholine) is an oral drug which has proven to be effective for the treatment of Visceral leishmaniasis (VL) in the Indian sub-continent. It has also been tested for CL, yielding varying results. Miltefosine was approved by FDA in 2014 for the treatment of CL in the New World for lesions due to L. braziliensis, L. panamensis and L. guyanensis only.

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-08-10
• Completion: 2019-09-10
• First posted: 2016-02-23
• Last updated: 2019-09-12

Locations

2 sites across 2 countries: Colombia, Peru