A Phase 2 interventional study of Topical Amphotericin-B 0.4% liposomal gel in Leishmaniasis, sponsored by Soroka University Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Soroka University Medical Center · Phase 2, Interventional, and Treatment
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's enrollment of 13 is below the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Soroka University Medical Center is the lead sponsor of 157 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical Amphotericin-B 0.4% liposomal gel
Drug: Topical Amphotericin-B 0.4% liposomal gel
Placebo gel preparation
Drug: Topical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Complete re-epithelization
Absence of ulceration, induration, erosion and
Time frame: Day 28 from enrollement
Lesion size
Defined by the multiplication of lesion length and width
Time frame: Day 28 and day 56 from enrollement
Complete re-epithelization
Time frame: Day 28 from enrollement
Skin manifestations
Pruritus, pain, etching, discharge, bloating
Time frame: Day 28 and day 56 from enrollement
Evidence of lesihmania infection
Evaluated by PCR test from a sample acquired from the lesion
Time frame: Day 56 from enrollement
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Soroka University Medical Center