WartsNCT05371834
Microwave Treatment of Common and Plantar Warts
A study testing Microwave Treatment (Swift System) and Cryotherapy in people with Warts, run by Blackwell Device Consulting at 6 sites in United States.
Trial summary
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Warts
- What is being tested?
- Microwave Treatment (Swift System) and Cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Jul 2022to Mar 2025
- Phase
- Interventional
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Age 18-64 years inclusive;
- A minimum of one clinically significant common wart (usually found on hands, knees and elbows), or one plantar wart. Note: the warts for treatment cannot be a mixture of common and plantar warts;
- Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive;
- If currently receiving treatment for common or plantar warts, agree to stop their current medication for at least 28 days prior to the start of study treatment;
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- Agrees to refrain from using any other wart removal products or treatments during the study period;
- Agrees to not take any non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within a 12-hour period prior to and after randomized treatment;
- Able to perform study assessments.
Who cannot join
- Pregnancy or breast feeding;
- Mosaic warts for treatment;
- Warts (common or plantar) that have been reported by the subject as present for more than 5 years (relates to any wart present and which may not necessarily be treated in this study);
- Warts for treatment on areas of thin or sensitive skin as determined by the Investigator, e.g., face, neck, armpits, breasts, buttocks or genitals;
- Areas for treatment where the skin is irritated, reddened or showing any sign of inflammation (e.g. itching and swelling);
- Warts for treatment with hair growth, birthmarks, dark moles, pigmented skin or any other unusual skin condition;
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- History of infection in designated treatment area within 90 days prior to first treatment;
- Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices;
- Metal implants at site of treatment (within foot or ankle);
- Known allergy or intolerance to microwave therapy and cryotherapy;
- Unstable co-morbidities (cardiovascular disease, active malignancy, inflammatory arthritis);
- Participating in another interventional study or have done so within the last 30-days;
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures;
- Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions;
- Peripheral neuropathy;
- Subject with known immunosuppression disorders through illness or medication (for example - corticosteroids, biologic agents, methotrexate, ciclosporin);
- Subject with autoimmune disease;
- Diabetes (Type I or II);
- History of vascular interventions to the legs, deemed as an unacceptable risk by the Investigator;
- Prior dissection of axillary lymph nodes (for treated hand) or inguinal lymph nodes (for treated feet);
- Dependent lymphedema;
- Congestive heart failure;
- History of repeated cellulitis (2 or more episodes);
- History of deep venous thrombosis;
- Subject currently receiving prescribed blood thinning medication;
- Subject who has ever had any topical metallic treatment (e.g, aluminum chloride, silver nitrate) within the past year.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Weil Foot & Ankle Institute
Chicago, Illinois, 60642
Miami Dermatology and Laser Institute
Miami, Florida, 33173
Oak Dermatology
Naperville, Illinois, 60563
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
TrueBlue Clinical Research
Palm Harbor, Florida, 34685
TrueBlue Clinical Research
Tampa, Florida, 33609
About this study
Official title: Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy.
Read the detailed description
The primary objective of this study is to collect evidence of the effectiveness of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy.
The secondary objectives of this study are to collect evidence of the safety, effectiveness and patient experiences of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy.
Eligible subjects who provide written informed consent will be randomized to either Microwave Treatment or Cryotherapy. Each eligible subject will receive treatment at the baseline visit (Visit 2) and again 4-weeks later. Subjects will receive a minimum of 2 treatments or, if further treatment is required, up to a maximum of 4 treatments; each treatment is given in 4-week intervals. Follow-up is 12-weeks after the last treatment has been administered where the warts will be assessed for resolution. Further follow-up visits occur 6-months and 12-months after the last treatment where the warts will be assessed for resolution or reoccurrence (if resolved at the 12-week visit).
- Conditions
- Warts
- Being tested
- Microwave Treatment (Swift System), Cryotherapy
- Keywords
- HPV, Human Papilloma Virus, Swift System, Microwave, Verruca, Common warts, Plantar Warts, Cryotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Treatment (Swift System)Device
Localized microwave energy applied to the wart lesion. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments).
For common warts (usually hands, elbow, knees): Treatment starts at 6W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeated on the same wart as is tolerable (3-5 repetitions).
For plantar warts: Treatment starts at 8W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeat on the same wart as is tolerable (3-5 repetitions).
Less power for a longer time will result in a more gradual temperature rise. Higher power for a shorter time will result in a more immediate temperature rise.
CryotherapyDevice
Local application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments).
| Study group | Role | What they receive |
|---|---|---|
| Microwave Treatment (Swift System) | Experimental | 5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion. Receives: Device: Microwave Treatment (Swift System) |
| Cryotherapy Treatment | Active comparator | For each wart, two cycles of cryotherapy treatment is administered. Receives: Device: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Measured: 3 months post final treatment
Secondary outcomes (9)
Clearance of all treated warts at three months post final treatment, each of which is defined as "lesion no longer visible" but assessed by the majority of three independent blinded assessors using photographs
Measured: 3 months post final treatment
Efficacy of all warts classed as resolved by the blinded site investigator at three months post final treatment, by the number of warts treated
Measured: 3 months post final treatment
Patient reported satisfaction with treatment at six and twelve months post final treatment
A patient reported satisfaction questionnaire will be completed. The questionnaire relates to how satisfied the subject was about their treatment and likes/ dislikes about their treatment.
Measured: 6 and 12 months post final treatment
Adverse events
Measured: 12 months post final treatment
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
Measured: 3 months, 6 months and 12 months post final treatment
Patient reported pain score since last treatment at three, six and twelve months post final treatment
The subject will be asked to rate the worst pain they have experienced (None, Mild, Moderate, Severe).
Measured: 3 months, 6 months and 12 months post final treatment
Reoccurrence of any treated wart at six and twelve months post final treatment, as classified by the blinded site investigator and separately by photos reviewed by the majority of the three independent blinded assessors.
Measured: 6 months and 12 months post final treatment
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at six months and twelve months post final treatment.
Measured: 6 months and 12 months post final treatment
The resolution rate for individual warts based on the classification by the blinded site investigator at 3 months post-final treatment.
Measured: 3 months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start6 Jul 2022
- Primary completionAug 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blackwell Device Consulting
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emblation Limited
- Responsible party
- Sponsor
- Investigators
- Dr Bhatia, Principal investigator, Oak Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371834
- Sponsor's protocol ID
- EMBHPV02
- Status last verified
- May 2024
- First submitted
- 5 May 2022
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts
- ClinicalTrials.gov ID
- NCT05371834
- Acronym / sponsor ID
- EMBHPV02
- Conditions
- Warts
- Keywords
- HPV, Human Papilloma Virus, Swift System, Microwave, Verruca, Common warts, Plantar Warts, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Blackwell Device ConsultingIndustry (pharma, biotech, devices)
- Collaborators
- Emblation Limited
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 12 May 2022 (actual)
- 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.
This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy.
Detailed description
The primary objective of this study is to collect evidence of the effectiveness of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy.
The secondary objectives of this study are to collect evidence of the safety, effectiveness and patient experiences of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy.
Eligible subjects who provide written informed consent will be randomized to either Microwave Treatment or Cryotherapy. Each eligible subject will receive treatment at the baseline visit (Visit 2) and again 4-weeks later. Subjects will receive a minimum of 2 treatments or, if further treatment is required, up to a maximum of 4 treatments; each treatment is given in 4-week intervals. Follow-up is 12-weeks after the last treatment has been administered where the warts will be assessed for resolution. Further follow-up visits occur 6-months and 12-months after the last treatment where the warts will be assessed for resolution or reoccurrence (if resolved at the 12-week visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave Treatment (Swift System) | Experimental | Device: Microwave Treatment (Swift System)5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion. |
| Cryotherapy Treatment | Active comparator | Device: CryotherapyFor each wart, two cycles of cryotherapy treatment is administered. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Age 18-64 years inclusive;
- A minimum of one clinically significant common wart (usually found on hands, knees and elbows), or one plantar wart. Note: the warts for treatment cannot be a mixture of common and plantar warts;
- Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive;
Key exclusion criteria (26 listed)
- Pregnancy or breast feeding;
- Mosaic warts for treatment;
- Warts (common or plantar) that have been reported by the subject as present for more than 5 years (relates to any wart present and which may not necessarily be treated in this study);
- Warts for treatment on areas of thin or sensitive skin as determined by the Investigator, e.g., face, neck, armpits, breasts, buttocks or genitals;
- Areas for treatment where the skin is irritated, reddened or showing any sign of inflammation (e.g. itching and swelling);
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 |
|---|---|---|
| Microwave Treatment (Swift System)Localized microwave energy applied to the wart lesion. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments). For common warts (usually hands, elbow, knees): Treatment starts at 6W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeated on the same wart as is tolerable (3-5 repetitions). For plantar warts: Treatment starts at 8W and applied locally for a 2 second burst and the dose and duration is adjusted (up or down) as is tolerable for the subject. Treatment is repeat on the same wart as is tolerable (3-5 repetitions). Less power for a longer time will result in a more gradual temperature rise. Higher power for a shorter time will result in a more immediate temperature rise. | Device | Microwave Treatment (Swift System) |
| CryotherapyLocal application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments). | Device | Cryotherapy Treatment |
Primary outcome
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Time frame: 3 months post final treatment
9 secondary outcomes
Clearance of all treated warts at three months post final treatment, each of which is defined as "lesion no longer visible" but assessed by the majority of three independent blinded assessors using photographs
Time frame: 3 months post final treatment
Efficacy of all warts classed as resolved by the blinded site investigator at three months post final treatment, by the number of warts treated
Time frame: 3 months post final treatment
Patient reported satisfaction with treatment at six and twelve months post final treatment
Time frame: 6 and 12 months post final treatment
Adverse events
Time frame: 12 months post final treatment
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
Time frame: 3 months, 6 months and 12 months post final treatment
Patient reported pain score since last treatment at three, six and twelve months post final treatment
Time frame: 3 months, 6 months and 12 months post final treatment
Reoccurrence of any treated wart at six and twelve months post final treatment, as classified by the blinded site investigator and separately by photos reviewed by the majority of the three independent blinded assessors.
Time frame: 6 months and 12 months post final treatment
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at six months and twelve months post final treatment.
Time frame: 6 months and 12 months post final treatment
The resolution rate for individual warts based on the classification by the blinded site investigator at 3 months post-final treatment.
Time frame: 3 months post final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Dr Bhatia principal investigator
Oak Dermatology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Treatment (Swift System) and Cryotherapy in people with Warts, run by Blackwell Device Consulting at 6 sites in United States.
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 9 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
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?
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total). (time frame: 3 months post final 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 21 May 2024.