Cutaneous Leishmaniasis
Conditions
Keywords
Cutaneous leishmaniasis, Pentoxifylline, Meglumine antimoniate, L. braziliensis
Brief summary
The purpose of this study is to determine whether pentoxifylline associated to pentavalent antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous leishmaniasis.
Interventions
DRUGPentoxifylline
Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.
DRUGPlacebo
Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.
Sponsors
Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Paulo Roberto Lima Machado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test). * Number of lesions: 1 to 3 ulcerative lesions. * Lesion´s diameter: 1 to 5 cm. * Disease duration: up to three months.
Exclusion criteria
* Safety concerns: * AST, ALT \>3 times upper limit of normal range * Serum creatinine or BUN \>1.5 times upper limit of normal range * Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary) * Immunodeficiency or antibody to HIV * Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases * Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months * Lack of suitability for the trial: * Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test * Any history of prior anti-leishmania therapy * Any condition which compromises ability to comply with the study procedures * Administrative reasons: * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * Anticipated non-availability for study visits/procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure rate or complete cicatrization of the ulcer. | 6 months | All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial cure rate or complete cicatrization of the ulcer | 2 months | All lesions will be categorized as either active or healed (cured) at follow-up visits. Only lesions with complete re-epithelialization, without raised borders, infiltrations or crusts will be considered healed. Evaluation of the lesions will be performed by 2 clinicians who will be unaware of the group assignment of all patients. Bidirectional measurements of ulcers will be taken of the patients' lesions at the initial visit, and at each follow-up visit with standardized caliper. The area involved will be calculated as the product of the two measurements |
Countries
Brazil
Outcome results
None listed