Microwave Treatment of Common and Plantar Warts

NCT05371834 | Active Not Recruiting FDA Device

• 1 other identifier: EMBHPV02
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Warts

Keywords

HPV; Human Papilloma Virus; Swift System; Microwave; Verruca; Common warts; Plantar Warts; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  3 months post final treatment

• Patient reported satisfaction with treatment at six and twelve months post final treatment

  6 and 12 months post final treatment

• Adverse events

  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

  3 months, 6 months and 12 months post final treatment

Study Arms (2)

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.

Device: Microwave Treatment (Swift System)

Cryotherapy Treatment

ACTIVE COMPARATOR

For each wart, two cycles of cryotherapy treatment is administered.

Device: Cryotherapy

Interventions

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.

Microwave Treatment (Swift System)

Cryotherapy DEVICE

Local application of Cryotherapy. Treatment is in 4-week intervals (minimum of 2 treatments, maximum of 4 treatments).

Cryotherapy Treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Blackwell Device Consulting: lead
• Emblation Limited: collaborator

Study Sites (6)

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

TrueBlue Clinical Research

Palm Harbor, Florida, 34685, United States

Location

TrueBlue Clinical Research

Tampa, Florida, 33609, United States

Location

Weil Foot & Ankle Institute

Chicago, Illinois, 60642, United States

Location

Oak Dermatology

Naperville, Illinois, 60563, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Warts

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dr Bhatia

  Oak Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study, however, there is a blinded site investigator at each site who will not be aware of the treatment group the subject is assigned. The blinded site investigator will assess resolution and reoccurrence of the warts. Photos of the warts will be taken and these will be reviewed by three independent blinded assessors to assess wart resolution and reoccurrence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 12, 2022
• Study Start: July 6, 2022
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

US (6)