Status:
COMPLETED
Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis
Lead Sponsor:
Centro Internacional de Entrenamiento e Investigaciones Médicas
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether adding pentoxifylline to treatment of American cutaneous leishmaniasis with meglumine antimoniate increases the rate and speed of clinical response wi...
Detailed Description
Failure of first line therapies for cutaneous leishmaniasis is a public health issue. Since pathogenesis of dermal leishmaniasis is mediated by the immune and inflammatory responses, resolution of dis...
Eligibility Criteria
Inclusion
- Patients with clinical diagnosis of cutaneous leishmaniasis (parasitologic confirmation or presumptive biopsy plus a positive Montenegro skin test).
- Age between 18 and 65 years.
- Lesions of a duration equal to or greater than one month
- More than one lesion or single lesion greater than 3 cm in diameter.
- Willingness to participate in the study after being informed through a consent process approved by the institutional ethical review committee
Exclusion
- Pregnant or lactating women, and women who are planning to conceive during the study or that reject the use of birth control methods.
- Medical conditions that compromise the immune system (HIV infection, neoplasias, diabetes mellitus, autoimmune diseases, or use of corticosteroids, immunomodulators or antineoplastic drugs).
- Medical conditions that preclude the use of antimonials or pentoxifylline (cardiac, renal, hepatic or pancreatic disease or abnormalities).
- Alcohol abuse or use of recreational drugs that interfere with adherence to treatment
- Use of drugs with antileishmanial potential during the previous 13 weeks, including pentavalent antimonials, amphotericin B, miltefosine, and pentamidine
- Use of Theophylline , anticoagulants or antiarrhythmics.
- Diffuse or disseminated leishmaniasis.
- Mucosal involvement secondary to Leishmania infection.
- Incapacity to attend the study visits or any other condition that according to the investigator could interfere with adherence to study procedures.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01464242
Start Date
November 1 2011
End Date
December 1 2015
Last Update
August 23 2016
Active Locations (1)
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1
Corporación Centro Internacional de entrenamiento e Investigaciónes Médicas
Cali, Valle del Cauca Department, Colombia, 5930