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Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis

NCT03829917 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-02

No results posted yet for this study

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 of two treatments is proposed. The most attractive systemic therapy is the only oral agent, miltefosine during 28 days, and the most attractive local therapy is application of Paromomycin cream for 28 days.

Conditions

  • Cutaneous Leishmaniasis, American

Interventions

DRUG

Miltefosine and Paromomycin

28 days of miltefosine plus 28 days of Paromomycin cream

DRUG

miltefosine

28 days of miltefosine

DRUG

paromomycin

28 days of paromomycin creaam

Sponsors & Collaborators

  • Hospital Dermatológico de Jorochito

    collaborator UNKNOWN

  • Ministerio de Salud de Bolivia, Programa Nacional de Leishmaniasis

    collaborator UNKNOWN

  • Alfred Berman Foundation

    collaborator UNKNOWN

  • Fundacion Nacional de Dermatologia

    lead OTHER

Principal Investigators

  • JAIME SOTO, MD · Fundación Nacional de Dermatología

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-12-01
Completion
2020-12-31

Countries

  • Bolivia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829917 on ClinicalTrials.gov