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Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis — HECT  

Cutaneous Leishmaniasis Clinical Trial

Official title:
Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device

Clinical Trial Summary

Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.

Clinical Trial Description

n/a

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01277796
Study type Expanded Access
Source Universidad Peruana Cayetano Heredia
Contact Alejandro Llanos-Cuentas, MD, PhD
Phone 51-1-482-7739
Email elmer.llanos@upch.pe
Status Available
Phase N/A
View Details
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