Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02656797
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Actual Duration (Months): 44
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• Actual Enrollment: 13 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: Jan 30, 2018
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

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

Primary Outcome Measures

1. Complete re-epithelization [Day 28 from enrollement]

   Absence of ulceration, induration, erosion and

Secondary Outcome Measures

1. Lesion size [Day 28 and day 56 from enrollement]

   Defined by the multiplication of lesion length and width

2. Complete re-epithelization [Day 28 from enrollement]

3. Skin manifestations [Day 28 and day 56 from enrollement]

   Pruritus, pain, etching, discharge, bloating

4. Evidence of lesihmania infection [Day 56 from enrollement]

   Evaluated by PCR test from a sample acquired from the lesion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soroka University Medical Center	Beer Sheva		Israel

Sponsors and Collaborators

• Soroka University Medical Center

Investigators

• Principal Investigator: Amir Horev, MD, Soroka University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 15, 2016
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AMIR HOREV, Head, Pediatric dermatology Service, Soroka University Medical Center, Soroka University Medical Center: Leishmania major; Leishmania tropica; Amphotericin B
• Additional relevant MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous; Amphotericin B; Liposomal amphotericin B

Study Results

No Results Posted as of Mar 15, 2022