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

NCT01661296 | Completed Phase 4 DMC

• 1 other identifier: SPMC/09/10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cutaneous Leishmaniasis

Keywords

cutaneous leishmaniasis, heat therapy, antimony

Outcome Measures

Primary Outcomes (1)

• Time to heal lesion

  6 months after treatment

Secondary Outcomes (2)

• Tissue scarring

  12 months

• Recurrence/Relapse of lesion

  18 months

Study Arms (2)

Sodium stibogluconate

ACTIVE COMPARATOR

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

RFH therapy

ACTIVE COMPARATOR

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

Interventions

RFH therapy OTHER

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.

Also known as: Heat therapy

RFH therapy

Sodium stibogluconate DRUG

Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions

Also known as: Glucantine, SSG

Sodium stibogluconate

Eligibility Criteria

• Age: 1 Year - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• parasitologically confirmed diagnosis of cutaneous leishmaniasis

You may not qualify if:

• Multiple lesions (more than 4)

Sponsors & Collaborators

• Sarder Patel Medical College: lead
• Ohio State University: collaborator

Study Sites (1)

PBM Hospita and SP Medical College

Bikaner, Rajasthan, India

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Hyperthermia

Interventions

Diathermy; Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Ram A Bumb, MD

  PBM Hospital and SP Medical College, Bikaner, Rajasthan, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head of the Department of Dermatology

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

IN (1)