Status:
COMPLETED
Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis
Lead Sponsor:
Fundacion Nacional de Dermatologia
Collaborating Sponsors:
Hospital Dermatológico de Jorochito
Ministerio de Salud de Bolivia, Programa Nacional de Leishmaniasis
Conditions:
Cutaneous Leishmaniasis, American
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
Cure rate for L braziliensis bolivian CL has been 70%-80% for standard systemic and local monotherapies. It would benefit patients if cure rates could be consistently \>90%, so testing a combination o...
Detailed Description
Cutaneous leishmaniasis (CL) is endemic in the New World from approximately the US-Mexican border through Central America and the Northern part of South America down to the level of Rio de Janeiro. L...
Eligibility Criteria
Inclusion
- Inclusion and exlusion Criteria:
- Gender: Male or female
- Age: \>12 yrs of age
- Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2.
- Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.
- Previous treatment for leishmaniasis:
- No specific or putatively specific therapy (Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol) in the last 3 months
- Other diseases: No concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
Exclusion
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03829917
Start Date
February 1 2019
End Date
December 31 2020
Last Update
February 2 2021
Active Locations (1)
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1
Hopital, Dermatologico
Jorochito, SC, Bolivia, 00000