EFFICACY AND SAFETY OF THERMOTHERAPY IN COMBINATION WITH MILTEFOSINE COMPARED WITH MEGLUMINE ANTIMONIATE AND WITH MILTEFOSINE MONOTHERAPY FOR THE TREATMENT OF CUTANEOUS LEISHMANIASIS IN THE NEW WORLD: A PHASE III, OPEN-LABEL, MULTICENTER AND RANDOMIZED CLINICAL TRIA

Not Applicable

Completed

• Conditions: -B551 Cutaneous leishmaniasis; Cutaneous leishmaniasis; B551

• Registration Number: PER-073-20
• Lead Sponsor: DRUGS FOR NEGLECTED DISEASE INITIATIVE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-21
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Man or woman aged <:: 12 and S60 years (upper age limit according to local regulations), and weighing 30 kg or more.
• Patient with a confirmed diagnosis of C in at least one lesion, by at least one of the following methods: 1) microscopic identification of amastigotes in stained injured tissue, 2) demonstration of Leishmania by PCR or 3) culture
positive for promastigotes.

• Patient with an injury that meets the following criteria:
- Size> 0.5 cm and <4 cm (maximum diameter).
- Not located on the ear, face, near the mucous membranes or in a place where, in the opinion of the IP, it is difficult to apply TT.
-Patient with <4 LC lesions.
-Injury lasting less than 4 months according to the patient´s history.

• Patient able to give informed consent / assent in writing.
• In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.

Exclusion Criteria

• with a positive urine or blood pregnancy test at the time of screening or who is breastfeeding, or a woman of childbearing potential who does not agree to take appropriate contraceptives during the treatment period and until 0180. In Brazil: women of childbearing age fertile who do not agree to use two effective contraceptive methods: a barrier method and a highly effective method (defined in section 8.2.4) 30 days before the start of treatment and until the visit 0180
• History of clinically significant medical problems or treatment that may interact, either negatively or positively, with the treatment of cutaneous leishmaniasis, including any disease
immunocompromising.
• Have received treatment for the leishmaniasis entry lesion with any medication, including antimonials, which, in the opinion of the PI, could modify the course of the Leishmania infection, in the 8 weeks (56 days) before D1.
• Have a diagnosis or suspected diagnosis of mucocutaneous leishmaniasis based on a physical examination.
• ECG at screening: QTc above 400 ms for men and 450 ms for women.
• Have the following laboratory values ​​at the time of screening:
-Serial amylase and lipase: 2 times above the upper normal level *
-Serum creatinin: above the upper normal level *
-ALT or AST: 3 times above the upper normal level
Normal levels are obtained with the local laboratory.
• Patient who is not willing to attend study consultations or who cannot comply with follow-up consultations until 6 months.
• Known history of alcohol addiction / abuse.
• Hypersensitivity to miltefosine or antimonial drugs or to any excipient of the investigational drugs.
• Patient with Sjogren-Larson Syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified