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Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Primary Purpose

Leishmaniasis

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Topical Amphotericin-B 0.4% liposomal gel

About this trial

This is an interventional treatment trial for Leishmaniasis focused on measuring Leishmania major, Leishmania tropica, Amphotericin B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Soroka University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AM-B

Placebo

Arm Description

Topical Amphotericin-B 0.4% liposomal gel

Placebo gel preparation

Outcomes

Primary Outcome Measures

Complete re-epithelization

Absence of ulceration, induration, erosion and

Secondary Outcome Measures

Lesion size

Defined by the multiplication of lesion length and width

Complete re-epithelization

Skin manifestations

Pruritus, pain, etching, discharge, bloating

Evidence of lesihmania infection

Evaluated by PCR test from a sample acquired from the lesion

Full Information

NCT ID

NCT02656797

First Posted

January 13, 2016

Last Updated

March 12, 2022

Sponsor

Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02656797

Brief Title

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Official Title

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 30, 2018 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soroka University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leishmaniasis

Keywords

Leishmania major, Leishmania tropica, Amphotericin B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AM-B

Arm Type

Experimental

Arm Description

Topical Amphotericin-B 0.4% liposomal gel

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo gel preparation

Intervention Type

Drug

Intervention Name(s)

Topical Amphotericin-B 0.4% liposomal gel

Intervention Description

Topical Amphotericin-B 0.4% liposomal gel

Primary Outcome Measure Information:

Title

Complete re-epithelization

Description

Absence of ulceration, induration, erosion and

Time Frame

Day 28 from enrollement

Secondary Outcome Measure Information:

Title

Lesion size

Description

Defined by the multiplication of lesion length and width

Time Frame

Day 28 and day 56 from enrollement

Title

Complete re-epithelization

Time Frame

Day 28 from enrollement

Title

Skin manifestations

Description

Pruritus, pain, etching, discharge, bloating

Time Frame

Day 28 and day 56 from enrollement

Title

Evidence of lesihmania infection

Description

Evaluated by PCR test from a sample acquired from the lesion

Time Frame

Day 56 from enrollement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amir Horev, MD

Organizational Affiliation

Soroka University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Soroka University Medical Center

City

Beer Sheva

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

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