Skin Tag Removal Device for Skin Tags

Overseen By Natalya Likhareva

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UK Innovations GP LTD

Must not be taking: Blood thinners, Steroids

Disqualifiers: Skin cancer, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1-24 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to remove skin tags by cutting off their blood supply with a silicone band. It employs a non-invasive method that avoids freezing or burning, potentially offering a safer option. Participants will use either a manual or automatic version of the STR Skin Tag Removal device. Suitable candidates are adults with at least one untreated skin tag between 4mm and 6mm who can photograph the tag themselves. As an unphased trial, this study provides participants the chance to explore a potentially safer and innovative method for skin tag removal.

Do I need to stop taking my current medications to join the trial?

If you are currently taking blood thinners (except for low-dose aspirin) or steroids, you may need to stop as these are part of the exclusion criteria. The trial does not specify a washout period, so it's best to discuss with the trial team.

What prior data suggests that the STR Skin Tag Removal device is safe for skin tag removal?

Research has shown that the STR Skin Tag Removal device, available in manual and automatic versions, is safer and less invasive than traditional methods like freezing or burning. This device uses a silicone band to cut off the blood supply to the skin tag, reducing risk.

Previous studies have found that some unapproved skin tag removal creams can cause serious skin injuries. The STR device differs by avoiding harsh chemicals and using a gentle mechanical method considered non-invasive.

No specific reports of problems with the STR device itself have emerged, and its design aims to minimize skin damage. The focus on a non-invasive method suggests it is well-tolerated. However, the device is still under study and not yet widely approved for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STR Skin Tag Removal device because it offers a potentially more efficient and user-friendly method for removing skin tags compared to traditional treatments like cryotherapy, surgical excision, or over-the-counter topical solutions. Unlike these existing options, the STR device comes in both manual and auto versions, providing flexibility in application and potentially reducing the need for professional intervention. The goal is to achieve a 60% success rate in tag removal, which could streamline the process for both patients and healthcare providers. This device could represent a significant leap forward in making skin tag removal more accessible and less invasive.

What evidence suggests that the STR Skin Tag Removal device is effective for removing skin tags?

Research shows that the STR Skin Tag Removal device is promising for eliminating skin tags. In this trial, participants will join one of two groups: one using the manual version of the device and the other using the automatic version. Studies found that the manual version successfully removed 65% of the skin tags it treated. The automatic version achieved a 90% success rate for smaller tags up to 1 mm and 76% for tags up to 2 mm. The device cuts off the blood supply to the skin tag, causing it to fall off naturally. This method is less invasive than treatments like freezing or burning. Overall, the STR device appears to be an effective and safe way to remove skin tags. ^{1 6 7 8 9}

Who Is on the Research Team?

Sunil S Dhawan

Principal Investigator

Dermatology Clinical Research, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 22 years old or older.

Must be able to understand, speak, and read English sufficiently for completion of the trial

Subject has at least one skin tag meeting specific requirements: no previous attempts to remove the skin tag(s) of investigation, measuring between 2mm and 6mm at the base, not located around the eye, on the eyelid, or in the groin area, if treating two tags, only one may be located in axilla, free of any active skin infection & area to treat tag has no severe eczema, located in an area where participant can take a self-taken photo, does not require an evaluation by pathology at the time of screening, subject has access to the internet via smartphone to complete the eDiary

Exclusion Criteria

Has an allergy to latex

Subject states that they are currently pregnant or intending to become pregnant during the course of the study

Current or recent participation within the last 30 days in another interventional clinical trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive treatment using the STR device for skin tag removal

1-24 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• STR Skin Tag Removal device

Trial Overview 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.

How Is the Trial Designed?

Group I: Skin Tag removal using the Manual Version of the STR Experimental Treatment 1 Intervention

Goal: successful removal of 60% 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).

Group II: Skin Tag removal using the Auto Version of the STR Experimental Treatment 1 Intervention

Goal: successful removal of 60% 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).

Who Is Running the Clinical Trial?

UK Innovations GP LTD

Lead Sponsor

Trials

1

Recruited

200+

Lindus Health

Industry Sponsor

Trials

12

Recruited

17,000+

Advarra

Collaborator

Trials

4

Recruited

640+

Advarra

Industry Sponsor

Trials

5

Recruited

680+

Citations

1. lindushealth.com lindushealth.com/research/uki-skin-tag

Skin Tag Removal Device; A Clinical Study to Determine ... This clinical study is being run to see how safe and effective a new, investigational, non-invasive skin tag removal (STR) device is. It's a low-risk study ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06463613

NCT06463613 | Using a Novel Skin Tag Removal Device Skin Tag removal using the Auto Version of the STR. Goal: successful removal of 60% of the skin tags treated with the auto version of the STR device.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19336026/

New mechanical device for effective removal of skin tags in ... Successful outcome was highest (90%) for lesions up to 1 mm in base. For lesions up to 2 mm, the rate of successful outcome was 76 percent. The ...

4. amazon.com amazon.com/live/video/0565bbe6b8d34416b3357425272a2355

Watch How to use skin tag removal kit on Amazon Live Shop with expert advice from qingwashangmao in their latest video How to use skin tag removal kit.

5. health.harvard.edu health.harvard.edu/blog/skin-tag-removal-optional-but-effective-2020032319079

Skin tag removal: Optional but effective While home remedies are available, their efficacy is largely anecdotal and not supported by significant data. Some commercial kits contain ...

6. aarp.org aarp.org/health/conditions-treatments/fda-warning-skin-tag-removers/

FDA Warning: Avoid Skin Tag and Mole Removers The FDA is cautioning consumers not to purchase skin tag and mole removers online. Learn more about side effects of these unapproved ...

7. youtube.com youtube.com/watch?v=-IiUvv_F2Ho

FDA WARNS AGAINST SKIN TAG & MOLE REMOVAL ... The fda has issued a warning against these products these at home skin tag removers mole removers because they have the potential to cause harm.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9891211/

Serious Skin Injuries Following Exposure to Unapproved ... Unapproved topical mole and skin tag removers may be caustic and cause serious skin injuries. The images identified in our series, including those from Amazon.

9. trial.medpath.com trial.medpath.com/clinical-trial/931a8c8418df7d27/nct06463613-skin-tag-removal-device-clinical-study

Using a Novel Skin Tag Removal Device | MedPath The micro version of the STR study device has been designed to remove skin tags that measure 2-4mm at the base, and the standard version is designed to ...