Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis

Cutaneous Leishmaniasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381055
• Other study ID #: LCPX2011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 23, 2011
• Last updated: January 25, 2017
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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
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.

Locations

Country	Name	City	State
Brazil	Posto de Saúde de Corte de Pedra	Corte de Pedra	Tancredo Neves/Bahia

Sponsors (4)

Lead Sponsor	Collaborator
Paulo Roberto Lima Machado	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Bahia, Instituto Nacional de Ciência e Tecnologia de Doenças Tropicais (INCT-DT)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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	2 months