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Using a Novel Skin Tag Removal Device

NCT06463613 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-13

No results posted yet for this study

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

Interventions

DEVICE

STR Skin Tag Removal device with diary and follow-up

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.

Sponsors & Collaborators

  • Lindus Health

    collaborator INDUSTRY

  • Advarra

    collaborator INDUSTRY

  • UK Innovations GP LTD

    lead INDUSTRY

Principal Investigators

  • Sunil S Dhawan · Dermatology Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2025-11-30
Completion
2026-01-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463613 on ClinicalTrials.gov