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NCT Number: NCT02656797

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

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

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Key information

Conditions

Leishmaniasis Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soroka University Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Amphotericin-B 0.4% liposomal gel

Drug

Topical Amphotericin-B 0.4% liposomal gel

Primary outcomes

  1. Complete re-epithelization

    Time frame: Day 28 from enrollement

    Absence of ulceration, induration, erosion and

Secondary outcomes

  1. Lesion size

    Time frame: Day 28 and day 56 from enrollement

    Defined by the multiplication of lesion length and width

  2. Complete re-epithelization

    Time frame: Day 28 from enrollement

  3. Skin manifestations

    Time frame: Day 28 and day 56 from enrollement

    Pruritus, pain, etching, discharge, bloating

  4. Evidence of lesihmania infection

    Time frame: Day 56 from enrollement

    Evaluated by PCR test from a sample acquired from the lesion

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2016
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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