Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

Not Applicable

Completed

• Conditions: Achrochordon
• Interventions: Device: Digiclamp (Skin tag removal initial plus follow-up)

• Registration Number: NCT03259295
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-23
• Study Start: 2017-12-01
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-15
• Results First Submitted: 2021-12-06
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Results First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin tag removal initial visit plus follow-up	Digiclamp (Skin tag removal initial plus follow-up)	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.

Primary Outcome Measures

Name	Time	Method
Re-occurrence Rate of Skin Tags	3 months	Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.

Secondary Outcome Measures

Name	Time	Method
Percentage of Scar Tissue Formation Among Lesion Sites	3 months	Percentage of subjects who develop scar tissue or keloid at the site of removal
Percentage of Discoloration Among Subjects	3 months	Percentage of subjects who develop discoloration at the site of removal
Satisfaction With Pain Post Procedure	2 months post procedure	All study participants were asked three questions in a post procedure satisfaction survey.; 1. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied". Subjects were counted in each category and reported.
How Likely to Recommend the Procedure to Friends and Family	2 months post procedure	All study participants were asked a satisfaction survey post procedure and whether they would recommend the procedure to friends and family. Categories for response were: "very likely", "somewhat likely", "neither likely nor unlikely", "somewhat unlikely", "very unlikely". Subjects in each category were counted and reported.
Percentage of Pain/Numbness Where Skin Tag Was Removed	3 months	Percentage of subjects who develop pain/numbness at the site of removal
Satisfaction With What the Area Looked Like Post Procedure	2 months post procedure	All study participants were given a satisfaction survey 2 months post procedure. Subjects had to choose if they were "very satisfied:, "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied" with how the area looks where the skin tag used to be. Subjects in each category were counted and reported.
Percentage of Permanent Scars Among Lesion Sites	3 months	Percentage of subjects who develop a scar at the removal site

Trial Locations

Locations (1)

Office of Raymond Marquette, MD; 🇺🇸 Ocala, Florida, United States