RECRUITING

Using a Novel Skin Tag Removal Device

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-06-03

Study Completion:2024-08-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06463613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sunil S Dhawan, MD

CONTACT

(510) 797-4111

sdhaw@yahoo.com

Natalya Likhareva

CONTACT

(510) 797-4111

natalyal@ctr4derm.com

Study Locations (Sites)

Center for Dermatology Clinical Research, Inc.

Fremont, California, 94538

United States

Collaborators and Investigators

Sponsor: UK Innovations GP LTD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03

Study Completion Date2024-08-07

Study Record Updates

Study Start Date2024-06-03

Study Completion Date2024-08-07

Terms related to this study

Keywords Provided by Researchers

Skin Tag

Additional Relevant MeSH Terms

Achrochordon