Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

Achrochordon Clinical Trial

Official title:

Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259295
• Other study ID #: 20171314 - WIRB
• Secondary ID: PRO00002692
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: February 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achrochordon

Intervention

Device:
• Digiclamp (Skin tag removal initial plus follow-up)
Skin tag will be assessed for size, location, and overall appearance. After assessment and confirmation that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site. Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.

Locations

Country	Name	City	State
United States	Office of Raymond Marquette, MD	Ocala	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	XDG Technologies, LLC

Country where clinical trial is conducted

United States, 

References & Publications (4)

Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169. — View Citation

Kahana M, Grossman E, Feinstein A, Ronnen M, Cohen M, Millet MS. Skin tags: a cutaneous marker for diabetes mellitus. Acta Derm Venereol. 1987;67(2):175-7. — View Citation

Schmook T, Stockfleth E. Current treatment patterns in non-melanoma skin cancer across Europe. J Dermatolog Treat. 2003;14 Suppl 3:3-10. doi: 10.1080/jdt.14.s3.3.10. — View Citation

Watson BT, Hennrikus WL. Postaxial type-B polydactyly. Prevalence and treatment. J Bone Joint Surg Am. 1997 Jan;79(1):65-8. doi: 10.2106/00004623-199701000-00007. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-occurrence Rate of Skin Tags	Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.	3 months
Secondary	Percentage of Permanent Scars Among Lesion Sites	Percentage of subjects who develop a scar at the removal site	3 months
Secondary	Percentage of Scar Tissue Formation Among Lesion Sites	Percentage of subjects who develop scar tissue or keloid at the site of removal	3 months
Secondary	Percentage of Discoloration Among Subjects	Percentage of subjects who develop discoloration at the site of removal	3 months
Secondary	Percentage of Pain/Numbness Where Skin Tag Was Removed	Percentage of subjects who develop pain/numbness at the site of removal	3 months
Secondary	Satisfaction With Pain 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.	2 months post procedure
Secondary	Satisfaction With What the Area Looked Like 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.	2 months post procedure
Secondary	How Likely to Recommend the Procedure to Friends and Family	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.	2 months post procedure