Status:
COMPLETED
Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Cutaneous Leishmaniases
Eligibility:
All Genders
12-60 years
Phase:
PHASE3
Brief Summary
This study evaluates if the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine is safe and have a comparable cure rate with the current recommended first line trea...
Detailed Description
This randomized, open label, multi-centre, non-inferiority study aims to compare that the combination of thermotherapy (one application, 50⁰C for 30") and 3 weeks of miltefosine (2.5 mg/kg/day for 21 ...
Eligibility Criteria
Inclusion
- Males and females, aged ≥12 and ≤60 years old (upper age limit according to local regulations), and weighing ≥ 30Kg.
- 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 Polymerase Chain Reaction (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, or on a location that in the opinion of the Principal Investigator (PI) is difficult to apply the TT.
- Patient with ≤ 4 CL lesions.
- Duration of lesion less than 4 months by patient history.
- Patient able to give written informed consent/ assent form.
- In the opinion of the investigator, the patient is capable of understanding and complying with the protocol.
Exclusion
- Female with a positive urine or blood pregnancy test at screening or who is breast feeding or female at fertile age who does not agree to take appropriate effective contraception during treatment period and up to D180 visit. In Brazil: female at fertile age who does not agree to use two effective methods of contraception: one barrier method and one highly effective method (defined in section 8.2.4) 30 days prior to the treatment onset and up to D180 visit.
- History of clinically significant medical problems / treatment that might interact, either negatively or positively, with treatment of cutaneous leishmaniasis including any immunocompromising condition.
- Within 8 weeks (56 days) of Day 1, received treatment for the entry lesion 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.
- Has laboratory values at screening as follows:
- Serum creatinine: above upper normal level\*.
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST): 3 times above upper normal level\*.
- Normal ranges obtained from local laboratory.
- 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 addiction/ alcohol abuse.
- Hypersensitivity to miltefosine or any study medication excipients.
- Patients with Sjogren-Larson Syndrome.
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04515186
Start Date
January 26 2021
End Date
February 27 2024
Last Update
May 8 2025
Active Locations (6)
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1
Fundación Nacional de Dermatología
Santa Cruz de la Sierra, Bolivia
2
Instituto René Rachou Oswaldo Cruz Foundation- FIOCRUZ MINAS
Belo Horizonte, Minas Gerais, Brazil
3
Julio Muller University Hospital Federal University of Mato Grosso
Cuiabá, Brazil
4
Federal University of Bahia Immunology Department
Salvador, Brazil