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Procedure

Microwave Treatment vs Freezing for Warts

N/A
Recruiting
Led By Dr Bhatia
Research Sponsored by Blackwell Device Consulting
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 22-64 years inclusive;
Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months and 12 months post final treatment
Awards & highlights

Study Summary

This trial is testing whether a microwave system is better than freezing for treating warts. 110 people with warts will be randomly assigned to either the microwave group or the freezing group. The trial is controlled, meaning that the researchers are comparing the results of the two groups to each other, and blind-assessed, meaning that the people assessing the results don't know which group each person was in.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of microwave therapy may include discomfort, skin irritation, or swelling at the treatment site. Cryotherapy can cause pain during application, redness, blistering, and possible scarring on the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 64 years old.
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My warts are within the size range required for the study.
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I have at least one significant wart on my hand, knee, or elbow, or two on my feet.
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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months and 12 months post final treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months and 12 months post final treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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).
Secondary outcome measures
Adverse events
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
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
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Microwave Treatment (Swift System)Experimental Treatment1 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 TreatmentActive Control1 Intervention
For each wart, two cycles of cryotherapy treatment is administered.

Find a Location

Who is running the clinical trial?

Emblation LimitedIndustry Sponsor
3 Previous Clinical Trials
123 Total Patients Enrolled
Blackwell Device ConsultingLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Dr BhatiaPrincipal InvestigatorOak Dermatology

Media Library

Cryotherapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05371834 — N/A
Warts Research Study Groups: Microwave Treatment (Swift System), Cryotherapy Treatment
Warts Clinical Trial 2023: Cryotherapy Highlights & Side Effects. Trial Name: NCT05371834 — N/A
Cryotherapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371834 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would meet the criteria for entry into this research program?

"This trial is enrolling 110 individuals aged 18 to 64 who are afflicted with warts. Those interested must meet the following criteria: abstain from taking non-steroidal anti-inflammatory drugs (NSAIDs) or antihistamines within 12 hours of randomized treatments; signed informed consent form provided, willingness to comply with study procedures and availability for duration of study period; age between 22 to 64 years old inclusive; one clinically significant common wart ranging from 3mm - 10 mm in size or two plantar warts measuring between 3mm-20mm respectively (not a mixture); no other current treatments being taken for wart removal at least 28 days"

Answered by AI

Is the age qualification for this trial limited to individuals over twenty years of age?

"This trial mandates that eligible participants are 18 to 64 years old, in order to satisfy the selection criteria."

Answered by AI

Does this experiment currently have open registration?

"Affirmative. According to clinicaltrials.gov, the trial which was initially advertised on July 6th 2022 is currently recruiting 110 individuals from 3 different sites. The post has been last edited on November 14th 2022."

Answered by AI

How many individuals are currently participating in this clinical research?

"Indeed, clinicaltrials.gov confirms that enlistment is underway for this research initiative which was first introduced on July 6th 2022 and updated to its latest version on November 14th 2022. 110 participants are required from 3 distinct locations."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Tennessee Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
~45 spots leftby Apr 2025