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

Study acronym: G-MTF01
StatusNot Yet Recruiting
PhasePhase 1
Started
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Record status
This record was last updated September 8, 2025 (before its estimated July 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints: 1 to 2
    • Study description expanded, about 861 words
    • Publications: details revised at 4 of 8 entries
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07149753
Lead Sponsor Universidad Industrial de Santander
Collaborators: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Conditions
(from sponsor)		 Cutaneous Leishmaniasis, Cutaneous Leishmaniasis, American, Topical Administration
Related terms Leishmaniasis, Cutaneous, Leishmaniasis, Mucocutaneous
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov