Intralesional treatment for cutaneous leishmanisis
Phase 2
Recruiting
- Conditions
- Cutaneous leishmaniasisC03.752.300.500.400
- Registration Number
- RBR-44kg5x
- Lead Sponsor
- Hospital Eduardo de Menezes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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%
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>;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<br>;relapse rate in one year evaluated by number of relapsed patients at 12-month clinical assessment