Add-on Study of Pentoxifylline in Cutaneous Leishmaniasis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 without diminishing safety, and to identify immune correlates of the healing response.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Treatments: Meglumine Antimoniate; Pentoxifylline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.