Microwave Treatment of Common and Plantar Warts
Status unconfirmed · Not applicable
Conditions studied: Warts
In brief
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.
Key facts
- Study ID
- NCT05371834
- Run by
- Blackwell Device Consulting
- People needed
- 119
- Starts
- 2022-07-06
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-05-21
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- 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.
You may not qualify if…
- 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;
- 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;
Where it is running
- Miami Dermatology and Laser Institute — Miami, Florida, United States
- TrueBlue Clinical Research — Palm Harbor, Florida, United States
- TrueBlue Clinical Research — Tampa, Florida, United States
- Weil Foot & Ankle Institute — Chicago, Illinois, United States
- Oak Dermatology — Naperville, Illinois, United States
- Tennessee Clinical Research Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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