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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02656797
Other study ID # sor017715ctil
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 30, 2018
Est. completion date October 1, 2021

Study information

Verified date March 2022
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date October 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Soroka University Medical Center Beer Sheva

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete re-epithelization Absence of ulceration, induration, erosion and Day 28 from enrollement
Secondary Lesion size Defined by the multiplication of lesion length and width Day 28 and day 56 from enrollement
Secondary Complete re-epithelization Day 28 from enrollement
Secondary Skin manifestations Pruritus, pain, etching, discharge, bloating Day 28 and day 56 from enrollement
Secondary Evidence of lesihmania infection Evaluated by PCR test from a sample acquired from the lesion Day 56 from enrollement
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