Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

March 12, 2022 updated by: AMIR HOREV, Soroka University Medical Center
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, double blind, placebo controlled study. The study will include 108 patients with cutenous leishmaniasis of Leishmania species major and tropica, confired by Polymerase Chain Reaction of a sample from a lesion.

Cure rate will be compared between patients treated with Amphotericin-B 0.4% Liposomal Gel and patients treated with placebo gel preparation.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Soroka University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AM-B
Topical Amphotericin-B 0.4% liposomal gel
Drug: Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
PLACEBO_COMPARATOR: Placebo
Placebo gel preparation
Drug: Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete re-epithelization
Time Frame: Day 28 from enrollement
Absence of ulceration, induration, erosion and
Day 28 from enrollement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion size
Time Frame: Day 28 and day 56 from enrollement
Defined by the multiplication of lesion length and width
Day 28 and day 56 from enrollement
Complete re-epithelization
Time Frame: Day 28 from enrollement
Day 28 from enrollement
Skin manifestations
Time Frame: Day 28 and day 56 from enrollement
Pruritus, pain, etching, discharge, bloating
Day 28 and day 56 from enrollement
Evidence of lesihmania infection
Time Frame: Day 56 from enrollement
Evaluated by PCR test from a sample acquired from the lesion
Day 56 from enrollement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Amir Horev, MD, Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2018

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (ESTIMATE)

January 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor017715ctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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