Leishmaniasis, Cutaneous, Leishmania Braziliensis Complex, Leishmaniasis, American, Leishmaniasis; American, Cutaneous
Conditions
Keywords
leishmaniasis, L.braziliensis, paromomycin cream, intralesional pentamidine, leishmaniasis local therapy
Brief summary
This protocol will compare topical paromomycin to standard intralesional (IL) antimony (Sb) to placebo for L braziliensis in Bolivia.
Detailed description
Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients). After treatment, all patients will be followed for 1, 3, and 6 months.
Interventions
topical application 2 times a day during 20 days
DRUGPentamidine Isethionate
3 Intralesional injections at days 1,3 and 5
OTHERPlacebo
topical application 2 times a day during 20 days
Sponsors
Fundacion Nacional de Dermatologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Group 1 (Paromomycin cream) will be compared to Group 3 (Vehicle cream). Both creams will have very similar physical characteristics and package. Group 2 (intralesional injection of pentamidine) will not be masked.
Intervention model description
Patients will be randomized between Paromomycin cream applied topically once daily for 20 days (group 1--40 patients), pentamidine administered intralesionally at 120 ug/mm2 on days 1, 3, 5 (group 2-20 patients), and cream vehicle applied topically once daily for 20 days (group 3-20 patients).
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Gender: Male or female * Age: \>12 yrs of age * Presentation: 1-to-2 ulcerative lesions, each \< 30 mm in largest diameter and with a total lesion area \<900 mm2. * Parasitology: Parasitological confirmation of the lesion will be made by visualization or culture of Leishmania from the biopsy or aspirate of the lesion.
Exclusion criteria
* Previous treatment for leishmaniasis with Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol in the last 3 months. * Other diseases that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Lesion size | 6 months | change of lesion area at 6 months after treatment compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treated-related adverse events | 1 month | Adverse events will measured according to CTCAE 4.03 |
Countries
Bolivia
Outcome results
None listed