Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

Sponsor

Paulo Roberto Lima Machado (Other)

Overall Status

Completed

CT.gov ID

NCT01381055

Collaborator

Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT) (Other), Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Federal University of Bahia (Other)

164

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Leishmaniasis	Drug: Pentoxifylline Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis

Actual Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pentoxifylline plus antimony	Drug: Pentoxifylline 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.
Placebo Comparator: Placebo plus antimony	Drug: Placebo 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.

Arm

Intervention/Treatment

Experimental: Pentoxifylline plus antimony

Drug: Pentoxifylline

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.

Placebo Comparator: Placebo plus antimony

Drug: Placebo

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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