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
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Leishmaniasis||Other: RFH therapy Drug: Sodium stibogluconate||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- Time to heal lesion [ Time Frame: 6 months after treatment ]
- Tissue scarring [ Time Frame: 12 months ]
- Recurrence/Relapse of lesion [ Time Frame: 18 months ]
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
|PBM Hospita and SP Medical College|
|Bikaner, Rajasthan, India|
|Principal Investigator:||Ram A Bumb, MD||PBM Hospital and SP Medical College, Bikaner, Rajasthan, India|