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Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis

NCT07149753 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug MILTEFOSINE, used topically in a hydrogel, works to treat non-complicated cutaneous leishmaniasis (CL) in adults. It will also learn about the safety of the drug MILTEFOSINE used topically. The main questions it aims to answer are:

* Is topical treatment with MILTEFOSINE hydrogel effective in patients with CL, thus justifying its continuation in the clinical phases (II and III) of development?
* What skin problems do participants have when using miltefosine hydrogels over CL lesions? Researchers will evaluate the safety and effectiveness of various concentrations of MILTEFOSINE hydrogel: 0.5%, 1.0%, and 1.5%.

Participants will:

* Apply the MILTEFOSINE hydrogel to the affected lesions daily for 28 consecutive days.
* Visit the Center at least two days prior to the study. This initial visit will include diagnostic tests, interviews, study information, informed consent, and the administration of the first doses. After this, patients are required to return to the clinic on day 28 and again three months later for additional check-ups and tests.
* Take a photo once a week for checkups, and keep a note of their symptoms

Conditions

  • Cutaneous Leishmaniasis
  • Cutaneous Leishmaniasis, American
  • Topical Administration

Interventions

DRUG

MILTEFOSINE gel

Each patient will receive a 30 g tube of G-MTF with instructions and recommendations for use. The first dose will be in the FOSCAL clinical studies unit; subsequent doses will be applied at the patient's site of origin based on their autonomy, once a day (morning or night). Instructions include washing hands thoroughly, cleaning the lesion, applying a thin layer of gel, leaving it uncovered for at least 15 minutes, avoiding contact with water until the next dose, and storing the gel properly during treatment.

Sponsors & Collaborators

  • Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

    collaborator OTHER

  • Universidad Industrial de Santander

    lead OTHER

Principal Investigators

  • Cristian Blanco, PhD · Universidad Industrial de Santander

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-07-20
Completion
2026-08-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149753 on ClinicalTrials.gov