Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

University of Florida

Status: Completed

Conditions: Achrochordon

Treatments: Device: Digiclamp (Skin tag removal initial plus follow-up)

Study type: Interventional

Funder types: Other

Identifiers

NCT03259295

PRO00002692 (Other Identifier)

20171314 - WIRB

Details and patient eligibility

About

The objective of this study is to assess the efficacy of using the Digiclamp device to remove achrocordons (skin tags). The hypothesis is that utilizing the device will result in low rates of re-occurrence, scars, scar tissue and discoloration at the site of removal.

Full description

Achrocorodons, or skin tags, are superficial cutaneous lesions that occur most commonly among middle aged adults, obese persons and those who suffer from Type 2 Diabetes. In most cases, the tags are not bothersome but there are instances when they can become infected or irritated. There are several skin tag removal options available, including suture ligature, freezing, cautery or excision. These procedures are often done in a dermatology office and are an out-of-pocket cost.

The Digiclamp device was invented to make skin tag removal procedures more accessible. The Digiclamp represents a new option that when placed in the hands of primary care clinicians, it will allow them to remove skin tags without having to purchase expensive devices or to refer them to a Dermatologist. The device is disposable, and relatively painless when used correctly, and requires minimal training.

The investigator is planning to enroll 100 subjects, who will have skin tags removed using the Digiclamp device. Subjects will return for follow up at 2-3 months after skin tag removal.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag

Exclusion criteria

• Subjects with skin tags measuring greater than 1 centimeter width at the base
• Subjects whose skin tags appear infected or may need to be evaluated by pathology
• Subjects whose skin tags are located in genital areas or eyelids
• Pregnant subjects
• Subjects with bleeding disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Skin tag removal initial visit plus follow-up

Experimental group

Description:

Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device.

Treatment:

Device: Digiclamp (Skin tag removal initial plus follow-up)