Cutaneous leishmaniasis
Conditions
Interventions
This is an open and controlled randomized clinical trial to evaluate the efficacy and safety of treating cutaneous leishmaniasis with intralesional meglumine antimoniate+imiquimod compared to standard
V03.175.250
Sponsors
Empresa Brasileira de Serviços Hospitalares - EBSERH
Empresa Brasileira de Serviços Hospitalares - EBSERH
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of CL with up to 3 lesions, up to 5 cm in diameter, ulcerated or not, with confirmation by one or more methods (direct examination, histopathology, culture, polymerase chain reaction, indirect immunofluorescence or Montenegro intradermal staining), without previous treatment or treated more than 6 months ago; age greater than or equal to 18 years; both sexes; hormonal and barrier contraceptive method, in the case of female patients of childbearing age; completion of the free and informed consent form (TCLE)
Exclusion criteria
Exclusion criteria: Other forms of acute tegumentar leishmaniasis other than cutaneous; injuries located on the cephalic segment; pre-treatment electrocardiographic changes that contraindicate the use of pentavalent antimony; women of reproductive age without an effective contraceptive method or used inappropriately; pregnant and breastfeeding women; diagnosis of human immunodeficiency syndrome (AIDS); previous hypersensitivity reaction to AM or imiquimod; inability to understand and complete the free and informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an increase in the cure rate on D180 (±14 days) in the group treated with intralesional meglumine antimoniate associated with imiquimod, compared to the group treated with the antimoniate alone. Cure is defined as complete healing, with no infiltration, erythema or scaling. The main outcome of cure will be evaluated by survival curves and, to correct possible confounders, we will use risk ratio analysis through multivariate analysis by Cox regression. The analyzes will be conducted using the SAS 9.4 application. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that clinical (such as edema and local pain), laboratory and electrocardiographic adverse events will not be more frequent in the group treated with intralesional meglumine antimoniate associated with imiquimod, compared to the group treated with the antimoniate alone. Clinical adverse events will be assessed through clinical/dermatological examination. The laboratory tests evaluated will be the complete blood count, glutamic oxaloacetic transaminase (TGO), glutamic pyruvic transaminase (TGP), fasting blood glucose, amylase, lipase, urea and creatinine. Statistical analysis will be carried out by obtaining the frequencies of the variables of interest, with evaluation of the average and percentage referring to each group. To compare data between two treatment groups, Fisher's tests will be used for nominal variables and the Mann Whitney U test for quantitative variables. P < 0.05 will be considered significant. The analyzes will be conducted using the SAS 9.4 application.;It is expected to find an increase in the initial cure rate on D90 (±7 days) in the group treated with intralesional meglumine antimoniate associated with imiquimod, compared to the group treated with the antimoniate alone. Initial healing is defined as complete epithelialization of the lesion. The cure outcome will be evaluated using survival curves and, to correct possible confounders, we will use risk ratio analysis using multivariate analysis using Cox regression. The analyzes will be conducted using the SAS 9.4 application. | — |
Countries
Brazil
Contacts
Public ContactAridne Campos
Empresa Brasileira de Serviços Hospitalares - EBSERH
Outcome results
None listed