NCT03829917

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 2, 2021

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

January 30, 2019

Last Update Submit

February 1, 2021

Conditions

Cutaneous Leishmaniasis, American

Outcome Measures

Primary Outcomes (1)

  • Change in Size of cutaneous ulcers

    Complete healing of all lesions by 6 months after the beginning of therapy. Thus for a patient to be cured: no lesion could enlarge by 50%, relapse, or heal incompletely; and no new Leishmania-positive lesion can have appeared.

    2, 3, 4 and 6 months after the begining of therapy.

Study Arms (3)

Paromomycin and Miltefosine

EXPERIMENTAL

Paromomycin-Aquaphilic cream applied topically once daily for 28 days plus oral miltefosine pills 2.5 mg/day \[50 mg tid\] for 28 days.

Drug: Miltefosine and Paromomycin

Miltefosine

ACTIVE COMPARATOR

Miltefosine pills alone \[2.5 mg/day \[50 mg tid\] for 28 days. This group will also receive Aquaphilic-vehicle cream for 28 days

Drug: miltefosine

Paromomycin

ACTIVE COMPARATOR

Paromomycin-Aquaphilic cream applied topically once daily for 28 days.

Drug: paromomycin

Interventions

Miltefosine and ParomomycinDRUG

28 days of miltefosine plus 28 days of Paromomycin cream

Paromomycin and Miltefosine
miltefosineDRUG

28 days of miltefosine

Miltefosine
paromomycinDRUG

28 days of paromomycin creaam

Paromomycin

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hopital, Dermatologico

Jorochito, SC, 00000, Bolivia

Location

MeSH Terms

Conditions

Leishmaniasis, Mucocutaneous

Interventions

miltefosineParomomycin

Condition Hierarchy (Ancestors)

Leishmaniasis, CutaneousLeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • JAIME SOTO, MD

    Fundación Nacional de Dermatología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

February 4, 2019

Study Start

February 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

February 2, 2021

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

BO(1)