Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

Overview

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.

Full Title of Study: “Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2015

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Pentoxifylline plus antimony
  • Placebo Comparator: Placebo plus antimony

Clinical Trial Outcome Measures

Primary Measures

  • Cure rate or complete cicatrization of the ulcer.
    • Time Frame: 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 Measures

  • Initial cure rate or complete cicatrization of the ulcer
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paulo Roberto Lima Machado
  • Collaborator
    • Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Paulo Roberto Lima Machado, Associate Researcher – Hospital Universitário Professor Edgard Santos
  • Overall Official(s)
    • Paulo Roberto L Machado, MD, PhD, Principal Investigator, Federal University of Bahia

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