Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

• Conditions: Cutaneous Leishmaniasis

• Registration Number: NCT01277796
• Lead Sponsor: Universidad Peruana Cayetano Heredia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-14
• Last Update Submitted: 2011-01-14
• Study First Posted: 2011-01-17
• Last Update Posted: 2011-01-17

Recruitment & Eligibility

• Status: AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
• aged 8-80 years old
• with no more than 3 lesions
• ulcerative and non-ulcerative ulcers less than 4 cm diameter.
• allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
• capable of signing an informed consent or having capable guardians (in the case of minors).
• Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.

Exclusion Criteria

• lesions less than 2cm from the nose, mouth, ears, or eyes.
• clinically diagnosed with mucosal involvement.
• evidence of lymph node involvement on exam.
• unable or unwilling to commit to the treatment and follow-up plan.
• prior CL treatment within last 1 month.
• pregnant or lactating
• uncontrolled severe systemic illness or immunocompromised state.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified