Trial record 6 of 27 for:
Open Studies | "Leishmaniasis"
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
This study is currently recruiting participants.
Verified June 2011 by Hospital Universitário Professor Edgard Santos
Sponsor:
Hospital Universitário Professor Edgard Santos
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:
Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01381055
First received: June 23, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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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: | March 2012 (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:
- ASAT, ALAT >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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381055
Contacts
| Contact: Paulo Roberto L Machado, MD, PhD | 55-71-32377353 | prlmachado@hotmail.com |
| Contact: Edgar M Carvalho, MD, PhD | 55-71-32377353 | edgar@ufba.br |
Locations
| Brazil | |
| Posto de Saúde de Corte de Pedra | Recruiting |
| Corte de Pedra, Tancredo Neves/Bahia, Brazil, 40000 | |
| Contact: Mayra Dourado, Nurse 55-73-35535084 mayradourado@hotmail.com | |
| Contact: Ednaldo L Lago 55-73-35535084 | |
| Principal Investigator: Maria das Graças O Brito, MD | |
| Sub-Investigator: Luís Guimarães, MD | |
| Principal Investigator: Paulo Roberto L Machado, MD, PhD | |
| Sub-Investigator: Mayra Dourado, Nurse | |
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
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, Universidade Federal da Bahia |
| ClinicalTrials.gov Identifier: | NCT01381055 History of Changes |
| Other Study ID Numbers: | LCPX2011 |
| Study First Received: | June 23, 2011 |
| Last Updated: | June 23, 2011 |
| 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 Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Pentoxifylline Meglumine antimoniate Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Free Radical Scavengers Antioxidants Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013