Using a Novel Skin Tag Removal Device

Launched by UK INNOVATIONS GP LTD · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to remove skin tags, which are small, harmless growths on the skin. The device works by placing a small silicone band around the base of the skin tag. This band cuts off the blood supply to the tag, making it fall off over time. This method is less invasive than traditional options like freezing or burning, which means it could be safer and cause less discomfort.

To join the trial, participants need to be at least 22 years old and must have at least one skin tag that has not been treated before. The skin tag should be between 2mm and 6mm in size and located in an area where the participant can easily take a photo of it. Potential participants should also be able to read and speak English, and have access to the internet for follow-up activities. Those with certain health issues, such as skin cancer or bleeding disorders, cannot participate. If you meet these criteria, you could help test this new and promising way to remove skin tags!

Gender

ALL

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, 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