Using a Novel Skin Tag Removal Device

NCT06463613 | Active Not Recruiting FDA Device

• 1 other identifier: Pro00078334
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achrochordon

Keywords

Skin Tag

Outcome Measures

Primary Outcomes (1)

• Successful removal of skin tag

  Number of successful removals of treated acrochordons using the STR device

  Treatment, 1-24 days; Safety follow-up on days 30-37

Secondary Outcomes (1)

• Comfort and Safety Issues

  Treatment, 1-24 days; Safety follow-up on days 30-37

Study Arms (2)

Skin Tag removal using the Manual Version of the STR

EXPERIMENTAL

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).

Device: STR Skin Tag Removal device with diary and follow-up

Skin Tag removal using the Auto Version of the STR

EXPERIMENTAL

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).

Device: STR Skin Tag Removal device with diary and follow-up

Interventions

STR Skin Tag Removal device with diary and follow-up DEVICE

The Investigator will assign an STR version for use, stratifying the number of skin tags in each pool. The investigator will review the subject's skin tags and agree with the subject on the body location and skin tag that will be treated as well as whether the micro or standard size of the study device is appropriate. The Investigator will also verify that the skin tag does not present implications of cancerous tissue. After informed consent and reviewing device labeling, the subject will then have the band(s) placed on the skin tag(s) by the healthcare professional. Once the band has been placed, the Investigator will examine the skin tag, complete study documentation. The subject will then review trial diary instructions, including but not limited to the documentation of all observable characteristics regarding the banded skin tag(s). This diary is electronic (eDiary) and accessed through a secure website and must be fully completed to successfully finish the study.

Skin Tag removal using the Auto Version of the STR; Skin Tag removal using the Manual Version of the STR

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 22 years of age.
• Must be able to understand, speak, and read English sufficiently for completion of the trial.
• Subject has at least one skin tag meeting ALL of the following requirements:
• no previous attempts to remove the skin tag(s) of investigation, including skin tags that were treated in a previous version of this protocol
• measuring between 4mm and 6mm at the base. Skin tags measuring larger than 6mm can be rounded down based on investigator's discretion.
• 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, in the opinion of the Investigator, require an evaluation by pathology at the time of screening
• Subject has access to the internet via smartphone to complete the eDiary

You may not qualify if:

• Significant medical condition or other circumstance which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the trial or providing informed consent, or may prevent the subject from safely participating in the trial
• Any prior history of skin-related cancer
• Subject states that they are currently pregnant or intending to become pregnant during the course of the study
• Has an allergy to latex
• 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
• Currently immunocompromised by conditions such as diabetes (either Types 1 or 2, regardless of level of control) or receiving immunosuppressant therapy
• Current MRSA infection
• Diagnosis or any history of keloid or hypertrophic scarring
• Current or recent participation within the last 30 days in another interventional clinical trial

Sponsors & Collaborators

• UK Innovations GP LTD: lead
• Lindus Health: collaborator
• Advarra: collaborator

Study Sites (1)

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Study Officials

• Sunil S Dhawan

  Dermatology Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This pivotal investigational study is designed to evaluate the safety and efficacy of a skin tag removal (STR) study device. This is a non-significant risk interventional clinical study that will be conducted by a Clinical Research Organization (CRO) with a licensed dermatologist(s) to serve as Principal Investigator. There are two arms of the study that are only differentiated by the type of STR study device used; arm 1 will be conducted using the manual version, and arm 2 will use the automatic version.

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 18, 2024
• Study Start: June 3, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 7, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)