Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Information provided by (Responsible Party):
Paulo Roberto Lima Machado, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01381055
First received: June 23, 2011
Last updated: December 26, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Cutaneous Leishmaniasis
Drug: Pentoxifylline
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Trial Using Pentoxifylline Associated With Pentavalent Antimony in Cutaneous Leishmaniasis

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Cure rate or complete cicatrization of the ulcer. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 164
Study Start Date: January 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381055

Locations
Brazil
Posto de Saúde de Corte de Pedra
Corte de Pedra, Tancredo Neves/Bahia, Brazil, 40000
Sponsors and Collaborators
Paulo Roberto Lima Machado
Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Bahia
Investigators
Principal Investigator: Paulo Roberto L Machado, MD, PhD Federal University of Bahia
  More Information

No publications provided

Responsible Party: Paulo Roberto Lima Machado, Associate Researcher, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT01381055     History of Changes
Other Study ID Numbers: LCPX2011
Study First Received: June 23, 2011
Last Updated: December 26, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Universitário Professor Edgard Santos:
Cutaneous leishmaniasis
Pentoxifylline
Meglumine antimoniate
L. braziliensis

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic
Meglumine antimoniate
Pentoxifylline
Anti-Infective Agents
Antioxidants
Antiparasitic Agents
Antiprotozoal Agents
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014