Topical Liposomal Amphotericin B Gel Treatment for Cutaneous Leishmaniasis

Soroka University Medical Center

Status and phase: Completed; Phase 2

Conditions: Leishmaniasis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02656797

sor017715ctil

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

AM-B

Experimental group

Description:

Topical Amphotericin-B 0.4% liposomal gel

Treatment:

Drug: Topical Amphotericin-B 0.4% liposomal gel

Placebo

Placebo Comparator group

Description:

Placebo gel preparation

Treatment:

Drug: Topical Amphotericin-B 0.4% liposomal gel