Microwave Treatment of Common and Plantar Warts

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    110
  • sponsor
    Blackwell Device Consulting
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Updated on 4 October 2022
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Summary

This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 110 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.

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).

Details
Condition Warts
Treatment Cryotherapy, Microwave Treatment (Swift System)
Clinical Study IdentifierNCT05371834
SponsorBlackwell Device Consulting
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 22-64 years inclusive
A minimum of one clinically significant common wart (usually found on hands, knees and elbows), or two plantar warts. 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

Exclusion Criteria

Pregnancy or breast feeding
Mosaic warts
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, 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 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)
Prior vascular interventions to the legs
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 blood thinning medication
Subject who has ever had any topical metallic treatment (e.g, aluminum chloride, silver nitrate) within the past year
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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