Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Leishmaniasis Clinical Trial

Official title:

Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656797
• Other study ID #: sor017715ctil
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

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