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

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

NCT Number	NCT07149753
Lead Sponsor	Universidad Industrial de Santander Collaborators: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Conditions	Cutaneous Leishmaniasis, Cutaneous Leishmaniasis, American, Topical Administration
Enrollment	15 participants
Start Date	2026-01-01
Primary Completion	2026-07-20 (estimated)
Study Completion	2026-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-08