NCT01277796

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

First QC Date

January 13, 2011

Last Update Submit

January 14, 2011

Conditions

Cutaneous Leishmaniasis

Interventions

Heat pack conduction-heat therapyDEVICE

Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

LeishmaniasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alejandro Llanos-Cuentas, MD, PhD

    Universidad Peruana Cayetano Heredia

    PRINCIPAL INVESTIGATOR

  • Witzig Richard, MD, MPH

    Tulane Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Llanos-Cuentas, MD, PhD

CONTACT

51-1-482-7739elmer.llanos@upch.pe

Study Design

Study Type
expanded access
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 17, 2011

Last Updated

January 17, 2011

Record last verified: 2011-01