Leishmaniasis
Conditions
Keywords
Leishmania major, Leishmania tropica, Amphotericin B
Brief summary
Comparison between placebo gel treatment to topical liposomal amphotericin B gel treatment for cutaneous leishmaniasis of Leishmania species major and tropica.
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.
Interventions
DRUGTopical Amphotericin-B 0.4% liposomal gel
Topical Amphotericin-B 0.4% liposomal gel
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete re-epithelization | Day 28 from enrollement | Absence of ulceration, induration, erosion and |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion size | Day 28 and day 56 from enrollement | Defined by the multiplication of lesion length and width |
| Complete re-epithelization | Day 28 from enrollement | — |
| Skin manifestations | Day 28 and day 56 from enrollement | Pruritus, pain, etching, discharge, bloating |
| Evidence of lesihmania infection | Day 56 from enrollement | Evaluated by PCR test from a sample acquired from the lesion |
Countries
Israel
Outcome results
None listed