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

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ClinicalTrials.gov Identifier: NCT01661296
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Ram Awatar Bumb, Sarder Patel Medical College

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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Other: RFH therapy Drug: Sodium stibogluconate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of RFH Therapy as Treatment for CL Caused by Leishmania Tropica in India
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

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:
  • Glucantine
  • SSG

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 Name: Heat therapy




Primary Outcome Measures :
  1. Time to heal lesion [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. Tissue scarring [ Time Frame: 12 months ]
  2. Recurrence/Relapse of lesion [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • parasitologically confirmed diagnosis of cutaneous leishmaniasis

Exclusion Criteria:

  • Multiple lesions (more than 4)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661296


Locations
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India
PBM Hospita and SP Medical College
Bikaner, Rajasthan, India
Sponsors and Collaborators
Sarder Patel Medical College
Ohio State University
Investigators
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Principal Investigator: Ram A Bumb, MD PBM Hospital and SP Medical College, Bikaner, Rajasthan, India
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Responsible Party: Ram Awatar Bumb, Professor and Head of the Department of Dermatology, Sarder Patel Medical College
ClinicalTrials.gov Identifier: NCT01661296    
Other Study ID Numbers: SPMC/09/10
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Ram Awatar Bumb, Sarder Patel Medical College:
cutaneous leishmaniasis, heat therapy, antimony
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics