NOT YET RECRUITING
NCT07149753
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
Gender: All
Ages: 18 Years - 65 Years
Cutaneous Leishmaniasis
Cutaneous Leishmaniasis, American
Topical Administration