Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-25 @ 4:28 PM
Study NCT ID:
NCT03096457
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2017-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Paromomycin for Cutaneous Leishmaniasis in Bolivia
Sponsor:
Fundacion Nacional de Dermatologia
Organization:
Study Overview
Official Title:
Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
After treatment, all patients will be followed for 1, 3, and 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: