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Procedure
Skin Tag Removal Device for Skin Tags
N/A
Recruiting
Research Sponsored by UK Innovations GP LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults at least 22 years of age
Be older than 18 years old
Must not have
Current diagnosis of a bleeding disorder included but not limited to Hemophilia or Von Willebrand disease
Currently being treated with topical steroids at site of skin tag of interest or oral steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment, 1-14 days; safety follow up on day 30
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study a mechanical device called Skin Tag Removal (STR) for removing skin tags in adults. The device works by placing a silicone band around the base of the skin tag to cut off
Who is the study for?
This trial is for adults with skin tags. Participants must be willing to use the STR device, keep a diary of their experience, and attend follow-up appointments. Specific eligibility criteria are not provided, but typically participants should be in good general health without conditions that could interfere with the study.
What is being tested?
The trial is testing the effectiveness of a new mechanical device called STR for removing skin tags. It works by cutting off blood supply to the tag using a silicone band. The study includes keeping a diary and attending follow-ups to monitor results and any changes.
What are the potential side effects?
Since this method avoids freezing or burning tissue, it may have fewer side effects compared to other removal techniques. Potential side effects are not detailed but might include discomfort at the application site or minor skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bleeding disorder like Hemophilia or Von Willebrand disease.
Select...
I am using steroid creams or taking steroid pills for a skin tag.
Select...
I have diabetes or am taking medication that weakens my immune system.
Select...
I have a history of keloid or thick scarring.
Select...
I have had skin cancer in the past.
Select...
I have a current MRSA infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment, 1-14 days; safety follow up on day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment, 1-14 days; safety follow up on day 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Successful removal of skin tag
Secondary study objectives
Comfort and Safety Issues
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Skin Tag removal using the Manual Version of the STRExperimental Treatment1 Intervention
Goal: successful removal of 80% of the skin tags treated with the manual version of the STR device. Subjects will have up to two (2) tags treated, therefore, 50-100 subjects are anticipated for this arm. A total of 100 skin tags is the ITT (intention to treat). Subject pool to be divided (as equal as possible) between two band sizes; 2-4mm (micro), or 4-6mm (standard).
Group II: Skin Tag removal using the Auto Version of the STRExperimental Treatment1 Intervention
Goal: successful removal of 80% of the skin tags treated with the auto version of the STR device. Subjects will have up to two (2) tags treated, therefore, 50-100 subjects are anticipated for this arm. A total of 100 skin tags is the ITT (intention to treat). Subject pool to be divided (as equal as possible) between two band sizes; 2-4mm (micro), or 4-6mm (standard).
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Who is running the clinical trial?
UK Innovations GP LTDLead Sponsor
Lindus HealthIndustry Sponsor
9 Previous Clinical Trials
15,930 Total Patients Enrolled
AdvarraUNKNOWN
3 Previous Clinical Trials
438 Total Patients Enrolled
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