A device for removing skin tags

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

This study is testing a new device that helps adults remove skin tags at home by using a band to cut off their blood supply, making the process easier and safer than traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: UK Innovations GP LTD (Industry-sponsored)
• Locations: 1 site (Fremont, California)
• Trial ID: NCT06463613 on ClinicalTrials.gov

What this trial studies

This study investigates a novel mechanical device designed to remove skin tags in adults using a ligation method. The device applies a silicone band around the base of the skin tag, restricting its blood supply, which is essential for its growth. This approach is considered less invasive compared to traditional methods like freezing or burning, potentially reducing risks associated with skin tag removal. Participants will use the device at home and maintain a diary for follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with at least one skin tag that meets specific size and location criteria.

Not a fit: Patients with significant medical conditions or those requiring pathology evaluation for their skin tags may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a safer and more convenient option for patients seeking to remove skin tags.

How similar studies have performed: While there have been studies on various skin tag removal methods, this specific ligation approach using a home device is relatively novel.

Eligibility criteria

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
   2. measuring between 2mm and 6mm at the base
   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

Where this trial is running

Fremont, California

• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States (Recruiting)

Study contacts

• Study coordinator: Sunil S Dhawan, MD

Conditions Achrochordon; Skin Tag