Microwave Treatment of Common and Plantar Warts

NCT ID: NCT05371834

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2025-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Microwave Treatment (Swift System)

Intervention Type: 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.

Cryotherapy Treatment

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

Group Type: ACTIVE_COMPARATOR

Cryotherapy

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Cryotherapy

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form;

2. Stated willingness to comply with all study procedures and availability for the duration of the study;

3. Age 18-64 years inclusive;

4. 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;

5. Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive;

6. 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;

7. Agrees to refrain from using any other wart removal products or treatments during the study period;

8. Agrees to not take any non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within a 12-hour period prior to and after randomized treatment;

9. Able to perform study assessments.

Exclusion Criteria

1. Pregnancy or breast feeding;

2. Mosaic warts for treatment;

3. 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);

4. Warts for treatment on areas of thin or sensitive skin as determined by the Investigator, e.g., face, neck, armpits, breasts, buttocks or genitals;

5. Areas for treatment where the skin is irritated, reddened or showing any sign of inflammation (e.g. itching and swelling);

6. Warts for treatment with hair growth, birthmarks, dark moles, pigmented skin or any other unusual skin condition;

7. History of infection in designated treatment area within 90 days prior to first treatment;

8. Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices;

9. Metal implants at site of treatment (within foot or ankle);

10. Known allergy or intolerance to microwave therapy and cryotherapy;

11. Unstable co-morbidities (cardiovascular disease, active malignancy, inflammatory arthritis);

12. Participating in another interventional study or have done so within the last 30-days;

13. Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures;

14. Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions;

15. Peripheral neuropathy;

16. Subject with known immunosuppression disorders through illness or medication (for example - corticosteroids, biologic agents, methotrexate, ciclosporin);

17. Subject with autoimmune disease;

18. Diabetes (Type I or II);

19. History of vascular interventions to the legs, deemed as an unacceptable risk by the Investigator;

20. Prior dissection of axillary lymph nodes (for treated hand) or inguinal lymph nodes (for treated feet);

21. Dependent lymphedema;

22. Congestive heart failure;

23. History of repeated cellulitis (2 or more episodes);

24. History of deep venous thrombosis;

25. Subject currently receiving prescribed blood thinning medication;

26. Subject who has ever had any topical metallic treatment (e.g, aluminum chloride, silver nitrate) within the past year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emblation Limited

INDUSTRY

Sponsor Role: collaborator

Blackwell Device Consulting

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Bhatia

Role: PRINCIPAL_INVESTIGATOR

Oak Dermatology

Locations

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

Countries

United States

Other Identifiers

EMBHPV02

Identifier Type: -

Identifier Source: org_study_id