Microwave Treatment vs Freezing for Warts

Recruiting at 5 trial locations

Overseen By Emblation

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Blackwell Device Consulting

Must not be taking: NSAIDs, Antihistamines, Blood thinners

Disqualifiers: Pregnancy, Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8-16 weeks

119 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two treatments for common and plantar warts: Microwave Treatment and Cryotherapy. Microwave Treatment uses heat to destroy the wart, while Cryotherapy uses freezing. The study aims to see which method is more effective and safe for patients.

Will I have to stop taking my current medications?

If you are currently receiving treatment for common or plantar warts, you will need to stop your current medication for at least 28 days before starting the study treatment. Additionally, you should not take any non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within 12 hours before and after the treatment.

What data supports the effectiveness of cryotherapy and microwave treatment for warts?

Cryotherapy, which involves freezing warts with liquid nitrogen, is a widely used and effective treatment for common and genital warts, although it often requires multiple sessions and can be painful. Local hyperthermia, a treatment similar to microwave therapy, has shown similar effectiveness to cryotherapy for plantar warts, with lower pain and recurrence rates. ^{1 2 3 4 5}

Is cryotherapy safe for treating warts?

Cryotherapy, which involves freezing warts, is generally considered safe, but it can cause pain during treatment and has a relatively high recurrence rate. Some studies report adverse events, but these are within acceptable limits and can be minimized by following guidelines. ^{2 5 6 7 8}

How does microwave treatment for warts differ from cryotherapy?

Microwave treatment for warts, like the Swift System, uses heat to target the wart, which can result in less pain and lower recurrence rates compared to cryotherapy (freezing with liquid nitrogen), which is often painful and may require multiple sessions. ^{2 5 9 10 11}

Research Team

Dr Bhatia

Principal Investigator

Oak Dermatology

Eligibility Criteria

This trial is for adults aged 22-64 with at least one significant common wart (3mm-10mm) or plantar wart (3mm-20mm), not mixed. Participants must stop current wart treatments 28 days before, avoid NSAIDs and antihistamines around treatment times, and commit to the study duration without using other wart products.

Inclusion Criteria

I agree to stop my current wart treatment 28 days before the study starts.

I am between 22 and 64 years old.

My warts are within the size range required for the study.

Exclusion Criteria

I have warts with hair growth, birthmarks, dark moles, or unusual skin conditions.

I have a condition or take medication that weakens my immune system.

You have an implanted device like a defibrillator or pacemaker.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Microwave Treatment or Cryotherapy for common and plantar warts. Each eligible subject will receive treatment at the baseline visit and again 4-weeks later, with a minimum of 2 treatments and up to a maximum of 4 treatments, each given in 4-week intervals.

8-16 weeks

2-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up is conducted 12 weeks after the last treatment, with further follow-up visits at 6 months and 12 months to assess wart resolution or reoccurrence.

12 months

3 visits (in-person)

Treatment Details

Interventions

• Cryotherapy
• Microwave Treatment (Swift System)

Trial Overview The trial compares two treatments for warts: Microwave Treatment using the Swift system versus Cryotherapy. It's a randomized controlled study where participants are assigned to either method without knowing which group they're in but outcomes are assessed blindly.

Participant Groups

Group I: Microwave Treatment (Swift System) Experimental Treatment 1 Intervention

5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion.

Group II: Cryotherapy Treatment Active Control 1 Intervention

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

Cryotherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cryotherapy for:

• Pain relief
• Inflammation reduction
• Muscle spasm treatment
• Rheumatoid arthritis
• Stress and anxiety relief

Approved in United States as Cryotherapy for:

• Pain management
• Muscle soreness reduction
• Recovery after exercise
• Fibromyalgia treatment
• Skin health improvement

Approved in Canada as Cryotherapy for:

• Pain relief
• Inflammation reduction
• Muscle spasm treatment
• Arthritis management
• Postpartum recovery

Who Is Running the Clinical Trial?

Blackwell Device Consulting

Lead Sponsor

Trials

2

Recruited

180+

Emblation Limited

Industry Sponsor

Trials

4

Recruited

240+

Findings from Research

Whole-body cryotherapy (WBC) has shown potential benefits for improving sleep quality, enhancing recovery after exercise, and alleviating chronic pain, with some evidence suggesting positive effects on mental health and cognitive functions due to increased BDNF levels.

Despite some safety concerns raised by health authorities regarding adverse events, a review of the literature indicates that the risks associated with true WBC are manageable and can be minimized by following established guidelines and recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. Legrand, FD., Dugué, B., Costello, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Monochloroacetic acid application is an effective alternative to cryotherapy for common and plantar warts in primary care: a randomized controlled trial. [2018]

2. Sweden pubmed.ncbi.nlm.nih.gov

Local Hyperthermia Versus Cryotherapy for Treatment of Plantar Warts: A Prospective Multi-centre Non-randomized Concurrent Controlled Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of long-pulsed Nd: YAG laser with cryotherapy in treatment of acral warts. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Management of genital infection caused by human papillomavirus. [2019]

5. Egypt pubmed.ncbi.nlm.nih.gov

Comparison of the Efficacy and Safety of Two Cryotherapy Protocols in the Treatment of Common Viral Warts: A Prospective Observational Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intralesional tuberculin purified protein derivative versus cryotherapy in the treatment of warts: An assessor-blinded, randomized controlled trial. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Cryotherapy of viral warts: a sustained 10-s freeze is more effective than the traditional method. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Cryotherapy to treat anogenital warts in nonimmunocompromised adults: Systematic review and meta-analysis. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Two-year experience of using the measles, mumps and rubella vaccine as intralesional immunotherapy for warts. [2022]