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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to investigate the use of a mechanical device to remove skin tags in adults. The device ("Skin Tag Removal", or STR) utilizes the ligation method by applying a silicone band around the base of a skin tag, therefore restricting the blood supply, which is vital to its growth and survival. Because this method does not include freezing or burning of tissue in or around the skin tag, it could be considered less invasive and less risky than other options.

Research Team

Sunil S Dhawan

Principal Investigator

Dermatology Clinical Research, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+