Efficacy of Radio-frequency Induced Heat (RFH)Therapy in Treatment of Cutaneous Leishmaniasis in India

August 31, 2012 updated by: Ram Awatar Bumb, Sarder Patel Medical College

An Open Label Study of RFH Therapy as Treatment for CL Caused by Leishmania Tropica in India

Infections caused by the protozoan parasite Leishmania include cutaneous (CL), mucosal (ML) and visceral leishmaniasis (VL). Over 12 million people currently suffer from leishmaniasis, and approximately 2 million new cases occur annually, making it a major global health problem. CL CL caused by Leishmania tropica is endemic around the city of Bikaner in Thar Desert region of the State of Rajasthan . WHO recommends antimonials such as sodium stibogluconate (SSG) to treat CL. However, these drugs are toxic and have poor patient compliance as they require multiple intramuscular or intralesional injections for 3 weeks. In addition, the emergence of drug-resistant strains is rapidly increasing worldwide. We are interested in novel treatments for CL that are safe, easy to administer and effective in inducing long-term cure. Recently, radio-frequency-induced heat (RFH) therapy has been used to treat CL. This treatment involves the controlled and localized delivery of radiofrequencies into lesions for 30-60 seconds under local anesthesia. Several short-term follow-up (4-5 months) studies as well as one long-term follow-up (12 months) study involving US soldiers who were infected with L. major in Iraq found that RFH therapy was comparable, or even better, than systemic antimonials. However, more studies are needed to establish long-term efficacy of RFH therapy in treatment of CL caused by other Leishmania species that are difficult to treat with conventional drugs, and to determine the risk of disease recurrence if any in patients living in Leishmania endemic regions. The goal of this trial is to compare long term efficacy of RFH therapy in treatment of CL caused by L. tropica in patients residing in Leishmania-endemic regions of India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study location and participants: Subjects for this study were recruited among children between the ages of 1-17 and adults between the ages of 18-85 who visit the dermatology outpatient clinic at PBM Hospital, Bikaner, with suspected CL. Informed consent was obtained from adults or from parents/legal guardians of minors for procedures and inclusion in the study. Individuals with any uncontrolled chronic medical condition, breast feeding, on immunosuppressive drugs or anticipated unavailability for follow-up were excluded from the study. Patients with more than 4 lesions were also excluded.

Study procedures: The diagnosis of CL was established by clinical examination, history of residence in an L. tropica-endemic area, and by microscopic examination of Giemsa-stained lesion smears for parasites (Leishmania tropica bodies) or lesion biopsy. For patients who were both smear and skin biopsy negative, PCR was used to detect parasites in the lesion tissue. The lesion and surrounding skin were cleaned with stabilized 0.1% chlorine dioxide solution, and local anesthesia was administered by subcutaneous injection of 2% Lidocaine around the lesion. RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds using a current field radio-frequency generator (ThermoMed 1.8; Thermosurgery Inc. USA). Patients were be prescribed an oral NSAID and topical antimicrobial cream for 5 days. Cure of infection and any recurrence was monitored by clinical follow-up at days 10 and months 1, 2, 3, 4, 6, 9, 12 and 18 months post-treatment.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Bikaner, Rajasthan, India
        • PBM Hospita and SP Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • parasitologically confirmed diagnosis of cutaneous leishmaniasis

Exclusion Criteria:

  • Multiple lesions (more than 4)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium stibogluconate
Intralesional SSG was administered in dose of 50 mg cm -2 of lesion once a week for 6 weeks (total six injections)
Drug: Sodium stibogluconate
Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions
Other Names:
  • SSG
  • Glucantine
Active Comparator: RFH therapy
RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia (1% lidocaine) using a current field radio-frequency generator (ThermoMed 1.8, Thermosurgery Inc).
Other: RFH therapy
RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia using a current field radio-frequency generator.
Other Names:
  • Heat therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to heal lesion
Time Frame: 6 months after treatment
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tissue scarring
Time Frame: 12 months
12 months
Recurrence/Relapse of lesion
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarder Patel Medical College

Collaborators

Ohio State University

Investigators

  • Principal Investigator: Ram A Bumb, MD, PBM Hospital and SP Medical College, Bikaner, Rajasthan, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 9, 2012

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPMC/09/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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