NCT03096457

Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia

Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fundacion Nacional de Dermatologia · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.

Detailed description

Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients). After treatment, all patients will be followed for 1, 3, and 6 months.

Conditions

• Leishmaniasis, Cutaneous
• Leishmania Braziliensis Complex
• Leishmaniasis, American
• Leishmaniasis; American, Cutaneous

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-15
• Primary completion: 2018-03-18
• Completion: 2018-04-01
• First posted: 2017-03-30
• Last updated: 2021-02-02

Locations

2 sites across 1 country: Bolivia