Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis (NCT07149753) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis
Colombia15 participantsStarted 2026-01-01
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of confirmed cutaneous leishmaniasis (CL)
* Age: 18 - 65 years.
* Patients who have 1-4 CL skin lesions with a diameter of 1-4 cm, with an evolution time of more than one month and not located on the face, ears, or joints.
* Patients WITHOUT suspected complicated CL (large regional lymphadenopathy, several large lesions spread to different parts of the body); NO mucosal leishmaniasis and NO suspicion of unusual leishmaniasis syndromes (e.g., recurrent leishmaniasis, diffuse or disseminated CL).
* Patients with NO history of systemic antileishmania treatment within 8 weeks prior to starting the study.
* Patients WITHOUT treatment failure with local therapy (intralesional antimonial injections or thermotherapy) or systemic therapy.
Exclusion Criteria:
* Pregnant or lactating women; women of reproductive age who refuse to use contraception until 45 days after treatment ends.
* Patients with cardiovascular, hepatic, or renal impairment or who report underlying diseases that medically compromise their participation in this study.
* Patients who report a history of immunodeficiency.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.