Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis
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ClinicalTrials.gov Identifier: NCT02656797 |
Recruitment Status :
Recruiting
First Posted : January 15, 2016
Last Update Posted : October 22, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leishmaniasis | Drug: Topical Amphotericin-B 0.4% liposomal gel | Phase 2 |
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 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 2021 |
Estimated Study Completion Date : | January 2022 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Amir Horev, MD | +97286400325 | amirhor@clalit.org.il | |
Contact: Mor Portnikov | +97286244245 |
Israel | |
Soroka University Medical Center | Recruiting |
Beer Sheva, Israel | |
Contact: Amir Horev amirhor@clalit.org.il |
Principal Investigator: | Amir Horev, MD | Soroka University Medical Center |
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: | October 22, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Leishmania major Leishmania tropica Amphotericin B |
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 |