Cutaneous LeishmaniasisPhase 4NCT01661296
Efficacy of Radio-frequency Induced Heat (RFH)Therapy in Treatment of Cutaneous Leishmaniasis in India
A Phase 4 study testing RFH therapy and Sodium stibogluconate in people with Cutaneous Leishmaniasis, run by Sarder Patel Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- RFH therapy and Sodium stibogluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- parasitologically confirmed diagnosis of cutaneous leishmaniasis
Who cannot join
- Multiple lesions (more than 4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- RFH therapy, Sodium stibogluconate
- Keywords
- cutaneous leishmaniasis, heat therapy, antimony
- Medical subject headings
- Leishmaniasis, Cutaneous, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFH therapyOther
Also called Heat 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.
Sodium stibogluconateDrug
Also called Glucantine, SSG
Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: RFH therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to heal lesion
Measured: 6 months after treatment
Secondary outcomes (2)
Tissue scarring
Measured: 12 months
Recurrence/Relapse of lesion
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarder Patel Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Ram Awatar Bumb, Sarder Patel Medical College
- Investigators
- Ram A Bumb, MD, Principal investigator, PBM Hospital and SP Medical College, Bikaner, Rajasthan, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661296
- Sponsor's protocol ID
- SPMC/09/10
- Status last verified
- Aug 2012
- First submitted
- 7 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of RFH Therapy as Treatment for CL Caused by Leishmania Tropica in India
- ClinicalTrials.gov ID
- NCT01661296
- Acronym / sponsor ID
- SPMC/09/10
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- cutaneous leishmaniasis, heat therapy, antimony
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sarder Patel Medical CollegeUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium stibogluconate | Active comparator | Drug: Sodium stibogluconateIntralesional SSG was administered in dose of 50 mg cm -2 of lesion once a week for 6 weeks (total six injections) |
| RFH therapy | Active comparator | Other: RFH therapyRFH 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). |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- parasitologically confirmed diagnosis of cutaneous leishmaniasis
Key exclusion criteria (1 listed)
- Multiple lesions (more than 4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFH therapyAlso: Heat therapyRFH 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 | RFH therapy |
| Sodium stibogluconateAlso: Glucantine, SSGSix intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions | Drug | Sodium stibogluconate |
Primary outcome
Time to heal lesion
Time frame: 6 months after treatment
2 secondary outcomes
Tissue scarring
Time frame: 12 months
Recurrence/Relapse of lesion
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram A Bumb, MD principal investigator
PBM Hospital and SP Medical College, Bikaner, Rajasthan, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RFH therapy and Sodium stibogluconate in people with Cutaneous Leishmaniasis, run by Sarder Patel Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to heal lesion (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.