Leishmaniasis
Conditions
Interventions
Group 1 - experimental: Paromomycin gel 10%, topical use, twice daily, for 30 days, in combination with a single application of intralesional infiltration of meglumine antimoniate on the first day of
Group 2 - control: Three intralesional injections of meglumine antimoniate with an interval of 15 days (± 3 days).
Drug
D02.033.800.813.550.800
D09.408.051.706
Sponsors
Banco Nacional de Desenvolvimento Nacional
Fundação Oswaldo Cruz
Eligibility
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Age group bigger then 12 years. Both sexes. Presence of skin lesions exclusively of ulcerated type with parasitological confirmation by at least one of the positive tests: anatomo-pathological, imprint, culture, PCR. Presence of a maximum of three lesions up to 3 cm in their largest diameter, in any location, except the face and ear. Agreement to participate voluntarily and signing the informed consent form. In the case of participants aged between 12 and 17 years, in addition to the parent's or legal guardian's consent, the minor's consent form will also be required.
Exclusion criteria
Exclusion criteria: Presence of mucosal involvement or presence of non-ulcerated lesion (papule, nodule, plaque, vegetative). Pregnancy or lactation. Systemic or topical use (in the lesion) of corticosteroids that cannot be suspended during the follow-up period in the study (between D1 and D180). Use of any treatment indicated for leishmaniasis within 90 days prior to inclusion in this study. 5. HIV infection or other immunodebilitating disease, defined as follows The. History of bone marrow transplantation less than 24 months ago or transplantation of solid organs at any interval, if using immunosuppressive therapy. B.Carriers of autoimmune disease in specific treatment or in activity (eg lupus, rheumatoid arthritis). c. Use of immunosuppressive or immunobiological drugs (with the exception of vaccines) in the 60 days prior to screening prior to screening. Drugs used in the treatment of autoimmune diseases (such as monoclonal antibodies, TNF alpha inhibitors, intracellular signaling blockers) are considered. d. Patients who received antineoplastic therapy in the 3 months prior to screening. and. Primary immunodeficiency patients. QTc interval on electrocardiogram greater than 450 ms for men and 460 ms for women31. Users of intravenous drugs or other chemical dependencies (including alcohol abuse. History of hypersensitivity to any study drug. Any condition that prevents follow-up with the frequency recommended by the study. 10. Secondary wound infection (in this case, wait for resolution with usual clinical treatment recommended in the service to reassess inclusion). If any previous topical medication is used, the patient must stop the application and may be included when there is no residue present.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the cure rate at 90 days of treatment initiation, defined by the percentage of patients with complete ulcer epithelialization (s) in relation to the total number of randomized participants for each treatment group, in the assessment of 90 days from the first day of treatment, with a margin of ± 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global rate of adverse events, defined as the number of events per participant, in relation to the total number of randomized participants for each treatment group, assessed at various times, at the end of the treatment phase, in the assessment of D90 and D180, if applicable.;Rate of serious adverse events, defined as the number of serious events per participant, in relation to the total number of randomized participants for each treatment group, assessed at various times, at the end of the treatment phase, in the assessment of D90 and D180.;Cure rate 180 days after the start of treatment, defined by the percentage of patients with complete epithelialization of the ulcer (s) associated with the absence of local infiltration, in relation to the total number of randomized participants for each treatment group, in the assessment of 180 days from the first day of treatment, with a margin of ± 4 weeks. ;Percentage of treatment interruption due to adverse event, defined as the number of participants with treatment suspended due to adverse event, in relation to the total number of randomized participants for each treatment group, assessed at the end of the treatment phase. | — |
Countries
Brazil
Contacts
Public ContactGláucia Cota
Centro de Pesquisa Rene Rachou, Fundação Oswaldo Cruz
Outcome results
None listed