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Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

Primary Purpose

Cutaneous Leishmaniasis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Pentoxifylline
Placebo
Sponsored by
Paulo Roberto Lima Machado
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Leishmaniasis focused on measuring Cutaneous leishmaniasis, Pentoxifylline, Meglumine antimoniate, L. braziliensis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Posto de Saúde de Corte de Pedra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pentoxifylline plus antimony

Placebo plus antimony

Arm Description

Outcomes

Primary Outcome Measures

Cure rate or complete cicatrization of the ulcer.
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
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

Full Information

First Posted
June 23, 2011
Last Updated
January 25, 2017
Sponsor
Paulo Roberto Lima Machado
Collaborators
Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01381055
Brief Title
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
Official Title
Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paulo Roberto Lima Machado
Collaborators
Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Leishmaniasis
Keywords
Cutaneous leishmaniasis, Pentoxifylline, Meglumine antimoniate, L. braziliensis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentoxifylline plus antimony
Arm Type
Experimental
Arm Title
Placebo plus antimony
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cure rate or complete cicatrization of the ulcer.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Initial cure rate or complete cicatrization of the ulcer
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Roberto L Machado, MD, PhD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Posto de Saúde de Corte de Pedra
City
Corte de Pedra
State/Province
Tancredo Neves/Bahia
ZIP/Postal Code
40000
Country
Brazil

12. IPD Sharing Statement

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Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

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