Cutaneous leishmaniasis
Conditions
Interventions
Infiltration of intralesional meglumine antimoniate in all 49 study subjects, 0.008 ml per mm2 of lesion area, weekly, 8 applications. There will be no placebo or no treatment group.
Drug
D01.268.513.124
Sponsors
Hospital Eduardo de Menezes
Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: volunteers with localized cutaneous form of leishmaniasis; both sexes; with up to maximum of three lesions and area of lesions of not more than 900mm2
Exclusion criteria
Exclusion criteria: Pretreatment with antileishmanial drugs for less than 6 months; History of allergy to meglumine antimoniate; Presence of congestive heart failure or cardiac arrhythmia; Medication with potential to cause cardiac arrhythmia; Pregnancy or lactation; Creatinine above 2 mg%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of intralesional infiltration evaluated by the absolute number and percentage of cured patients compared to treated patients. Cure is defined by complete epithelization of the lesion and no infiltration. | — |
Secondary
| Measure | Time frame |
|---|---|
| tolerance to the treatment evaluated by the number of patients with adverse events compared to all treated patients; a clinical and laboratory record previously set will be used ;description of pharmacokinetic property of antimony after intralesional infiltration performed by measurement of plasma level of antimony before and after 1,2,4 and 6 hours after ainfiltração ;relapse rate in one year evaluated by number of relapsed patients at 12-month clinical assessment | — |
Countries
Brazil
Contacts
Public ContactGláucia Cota
Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz
Outcome results
None listed