NCT02687971

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2016

Typical duration for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

February 17, 2016

Last Update Submit

September 11, 2019

Conditions

Cutaneous Leishmaniasis

Outcome Measures

Primary Outcomes (1)

  • Initial cure rate

    Initial Cure: Ulcerated lesions: 100% re-epithelialization of the lesion(s) by Day 90. Non-Ulcerated lesions: flattening and/or no signs of induration of the lesion(s) by Day 90. The percentage of re-epithelialization of the lesion(s) is calculated by comparing the size of the ulcer at Day 7 against the size at the follow up visit

    Day 90, after start of treatment

Secondary Outcomes (2)

  • Final cure rate

    Day 180, after star of treatment

  • Frequency and severity of AEs

    Day 45

Study Arms (2)

Thermotherapy alone

ACTIVE COMPARATOR

Local heat will be applied using a Localized Current Field radio-frequency generating device manufactured by Thermo-Med Technologies, Inc. A wand with 2 electrodes is connected to the main housing by a thin wire. The electrodes are applied to the skin. We will use electrodes 6 mm long, separated by 4 mm. One single session at the site of the lesion(s) at 50°C for 30" applications will be used. Depending on the size of the lesion, more than one application may be administered.

Drug: Miltefosine

Thermotherapy plus Miltefosine

EXPERIMENTAL

In addition to receiving one single session of thermotherapy as described above, subjects will receive oral miltefosine two or three capsules a day, which is the equivalent of 100 to 150mg respectively for 21 days. Miltefosine capsules will be taken after breakfast, lunch and dinner, in other words, after food. The daily dose of miltefosine will depend on the weight of each patient. According to dosage instructions if the patient is taking the miltefosine twice a day, it must be taken in the morning and night (dose of 100mg/Kg/day). Whereas if the patient is taking miltefosine three times a day, it must be taken in the morning, noon and night (dose of 150mg/Kg/day).

Drug: Miltefosine

Interventions

MiltefosineDRUG

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.

Also known as: Impavido
Thermotherapy aloneThermotherapy plus Miltefosine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \</= 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,
  • Patient with \</= 4 CL lesions,
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Programa de Estudios y Control de Enfermedades Tropicales (PECET), Universidad de Antioquia

Medellín, Colombia

Location

IMT Alexander Von Humboldt

Lima, Peru

Location

Related Publications (1)

  • Lopez L, Valencia B, Alvarez F, Ramos AP, Llanos-Cuentas A, Echevarria J, Velez I, Boni M, Rode J, Quintero J, Jimenez A, Tabares Y, Mendez C, Arana B. A phase II multicenter randomized study to evaluate the safety and efficacy of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. PLoS Negl Trop Dis. 2022 Mar 7;16(3):e0010238. doi: 10.1371/journal.pntd.0010238. eCollection 2022 Mar.

    PMID: 35255096DERIVED

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosine

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ivan Dario Velez, Prof

    PECET, Universidad de Antioquia, Medellin, Colombia

    PRINCIPAL INVESTIGATOR

  • Alejandro Llanos-Cuentas, MD, PhD

    Universidad Peruana Cayetano Heredia, Lima, Peru

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

February 23, 2016

Study Start

December 1, 2016

Primary Completion

August 10, 2019

Study Completion

September 10, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

PE(1)CO(1)