Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Phase 2

Completed

• Conditions: Leishmaniasis
• Interventions: Drug: Topical Amphotericin-B 0.4% liposomal gel

• Registration Number: NCT02656797
• Lead Sponsor: Soroka University Medical Center

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.

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2018-01-30
• Primary Completion: 2021-06-01
• Study Completion: 2021-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AM-B	Topical Amphotericin-B 0.4% liposomal gel	Topical Amphotericin-B 0.4% liposomal gel
Placebo	Topical Amphotericin-B 0.4% liposomal gel	Placebo gel preparation

Primary Outcome Measures

Name	Time	Method
Complete re-epithelization	Day 28 from enrollement	Absence of ulceration, induration, erosion and

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel