Status:
NOT_YET_RECRUITING
Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis
Lead Sponsor:
Universidad Industrial de Santander
Collaborating Sponsors:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Conditions:
Cutaneous Leishmaniasis
Cutaneous Leishmaniasis, American
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 s...
Detailed Description
Study universe/study population It is the department of Santander in Colombia. The department ranks third in Colombia for the highest number of CL cases, with an incidence of 57% of cases per 100,000 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07149753
Start Date
January 1 2026
End Date
August 30 2026
Last Update
September 8 2025
Active Locations (1)
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1
Calle 158 No. 20-95 Cañaveral
Floridablanca, Santander Department, Colombia