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Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656797
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
AMIR HOREV, Soroka University Medical Center

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

Condition or disease Intervention/treatment Phase
Leishmaniasis Drug: Topical Amphotericin-B 0.4% liposomal gel Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Complete re-epithelization [ Time Frame: Day 28 from enrollement ]
    Absence of ulceration, induration, erosion and


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656797


Contacts
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Contact: Amir Horev, MD +97286400325 amirhor@clalit.org.il
Contact: Mor Portnikov +97286244245

Locations
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Israel
Soroka University Medical Center Recruiting
Beer Sheva, Israel
Contact: Amir Horev       amirhor@clalit.org.il   
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Amir Horev, MD Soroka University Medical Center
More Information
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Responsible Party: AMIR HOREV, Head, Pediatric dermatology Service, Soroka University Medical Center, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02656797    
Other Study ID Numbers: sor017715ctil
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AMIR HOREV, Soroka University Medical Center:
Leishmania major
Leishmania tropica
Amphotericin B
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
 Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents