Clinical trial NCT03259295: Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp
Official title: Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achrochordon
Keywords: skin tag
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: XDG Technologies, LLC
First posted: 2017-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Re-occurrence Rate of Skin Tags
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Permanent Scars Among Lesion Sites
timeFrame: 3 months
measure: Percentage of Scar Tissue Formation Among Lesion Sites
timeFrame: 3 months
measure: Percentage of Discoloration Among Subjects
timeFrame: 3 months
measure: Percentage of Pain/Numbness Where Skin Tag Was Removed
timeFrame: 3 months
measure: Satisfaction With Pain Post Procedure
timeFrame: 2 months post procedure
measure: Satisfaction With What the Area Looked Like Post Procedure
timeFrame: 2 months post procedure
measure: How Likely to Recommend the Procedure to Friends and Family
timeFrame: 2 months post procedure
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Office of Raymond Marquette, MD
state: Florida
Study officials:
affiliation: University of Florida
name: Juan C Roig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.