Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06463613

Using a Novel Skin Tag Removal Device

Sponsor: UK Innovations GP LTD

View on ClinicalTrials.gov

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.

Official title: Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons (Skin Tags)

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-06-03

Completion Date

2026-01-07

Last Updated

2025-11-13

Healthy Volunteers

Yes

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.

Inclusion Criteria: 1. Adults at least 22 years of age. 2. Must be able to understand, speak, and read English sufficiently for completion of the trial. 3. Subject has at least one skin tag meeting ALL of the following requirements: 1. no previous attempts to remove the skin tag(s) of investigation, including skin tags that were treated in a previous version of this protocol 2. measuring between 4mm and 6mm at the base. Skin tags measuring larger than 6mm can be rounded down based on investigator's discretion. 3. not located around the eye, on the eyelid, or in the groin area 4. if treating two tags, only one may be located in axilla 5. free of any active skin infection \& area to treat tag has no severe eczema 6. located in an area where participant can take a self-taken photo 7. does not, in the opinion of the Investigator, require an evaluation by pathology at the time of screening 4. Subject has access to the internet via smartphone to complete the eDiary Exclusion Criteria: 1. 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 2. Any prior history of skin-related cancer 3. Subject states that they are currently pregnant or intending to become pregnant during the course of the study 4. Has an allergy to latex 5. Current diagnosis of a bleeding disorder included but not limited to Hemophilia or Von Willebrand disease 6. Currently being treated with blood thinners (use of 81 mg of Aspirin is not exclusionary) 7. Currently being treated with topical steroids at site of skin tag of interest or oral steroids 8. Currently immunocompromised by conditions such as diabetes (either Types 1 or 2, regardless of level of control) or receiving immunosuppressant therapy 9. Current MRSA infection 10. Diagnosis or any history of keloid or hypertrophic scarring 11. Current or recent participation within the last 30 days in another interventional clinical trial

Locations (1)

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States