NCT02656797

Brief Summary

Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2018

Typical duration for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

January 13, 2016

Last Update Submit

March 12, 2022

Conditions

Leishmaniasis

Keywords

Leishmania majorLeishmania tropicaAmphotericin B

Outcome Measures

Primary Outcomes (1)

  • Complete re-epithelization

    Absence of ulceration, induration, erosion and

    Day 28 from enrollement

Secondary Outcomes (4)

  • Lesion size

    Day 28 and day 56 from enrollement

  • Complete re-epithelization

    Day 28 from enrollement

  • Skin manifestations

    Day 28 and day 56 from enrollement

  • Evidence of lesihmania infection

    Day 56 from enrollement

Study Arms (2)

AM-B

EXPERIMENTAL

Topical Amphotericin-B 0.4% liposomal gel

Drug: Topical Amphotericin-B 0.4% liposomal gel

Placebo

PLACEBO COMPARATOR

Placebo gel preparation

Drug: Topical Amphotericin-B 0.4% liposomal gel

Interventions

Topical Amphotericin-B 0.4% liposomal gelDRUG

Topical Amphotericin-B 0.4% liposomal gel

AM-BPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cutenous leishmaniasis confirmed by PCR (Leishmania species major or tropica)
  • to 5 lesions
  • Signed informed consent

You may not qualify if:

  • Facial lesions
  • Significant co-morbidity
  • Pregnancy or breast-feeding at enrollment
  • Previous treatment for leishmaniasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Amir Horev, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Pediatric dermatology Service, Soroka University Medical Center

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

January 30, 2018

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)