Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 1, 2021

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.

Interventions

  • Drug: Topical Amphotericin-B 0.4% liposomal gel
    • Topical Amphotericin-B 0.4% liposomal gel

Arms, Groups and Cohorts

  • Experimental: AM-B
    • Topical Amphotericin-B 0.4% liposomal gel
  • Placebo Comparator: Placebo
    • Placebo gel preparation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Soroka University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: AMIR HOREV, Head, Pediatric dermatology Service, Soroka University Medical Center – Soroka University Medical Center
  • Overall Official(s)
    • Amir Horev, MD, Principal Investigator, Soroka University Medical Center

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