Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
NCT03096457 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-02-02
Summary
This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.
Conditions
- Leishmaniasis, Cutaneous
- Leishmania Braziliensis Complex
- Leishmaniasis, American
- Leishmaniasis; American, Cutaneous
Interventions
- DRUG
-
Paromomycin Sulfate
topical application 2 times a day during 20 days
- DRUG
-
Pentamidine Isethionate
3 Intralesional injections at days 1,3 and 5
- OTHER
-
Placebo
topical application 2 times a day during 20 days
Sponsors & Collaborators
-
Fundacion Nacional de Dermatologia
lead OTHER
Principal Investigators
-
JAIME SOTO, MD · Fundacion Nacional de Dermatologia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-15
- Primary Completion
- 2018-03-18
- Completion
- 2018-04-01
Countries
- Bolivia
Study Locations
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