Achrochordon Clinical Trial
Official title:
Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons (Skin Tags)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 7, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
Lead Sponsor | Collaborator |
---|---|
UK Innovations GP LTD | Advarra, Lindus Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful removal of skin tag | Number of successful removals of treated acrochordons using the STR device | Treatment, 1-14 days; Safety follow up on day 30 | |
Secondary | Comfort and Safety Issues | Amount and number of discomfort, issues or adverse events occurring during the study | Treatment, 1-14 days; Safety follow up on day 30 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03259295 -
Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp
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N/A |