NCT03259295

Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp

Completed NA Results posted Last updated 15 February 2023

What this trial tests

NA trial testing Digiclamp (Skin tag removal initial plus follow-up) in Achrochordon in 20 participants. Completed in 15 June 2019.

Timeline

1 December 2017

Primary endpoint
15 June 2019

15 June 2019

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2017
Primary completion	15 June 2019
Estimated completion	15 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Digiclamp (Skin tag removal initial plus follow-up)

Conditions studied

• Achrochordon — all drugs for Achrochordon →

Sponsor

University of Florida

Who can join

18 and older, any sex, with Achrochordon. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Re-occurrence Rate of Skin Tags Primary · 3 months

Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	0

Percentage of Permanent Scars Among Lesion Sites Secondary · 3 months

Percentage of subjects who develop a scar at the removal site

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	1

Percentage of Scar Tissue Formation Among Lesion Sites Secondary · 3 months

Percentage of subjects who develop scar tissue or keloid at the site of removal

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	0

Percentage of Discoloration Among Subjects Secondary · 3 months

Percentage of subjects who develop discoloration at the site of removal

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	3

Percentage of Pain/Numbness Where Skin Tag Was Removed Secondary · 3 months

Percentage of subjects who develop pain/numbness at the site of removal

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	0

Satisfaction With Pain Post Procedure Secondary · 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.

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	20
Skin Tag Removal Initial Visit Plus Follow-up	0
Skin Tag Removal Initial Visit Plus Follow-up	0
Skin Tag Removal Initial Visit Plus Follow-up	0

Satisfaction With What the Area Looked Like Post Procedure Secondary · 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.

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	19
Skin Tag Removal Initial Visit Plus Follow-up	1
Skin Tag Removal Initial Visit Plus Follow-up	0
Skin Tag Removal Initial Visit Plus Follow-up	0

How Likely to Recommend the Procedure to Friends and Family Secondary · 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.

Group	Value	95% CI
Skin Tag Removal Initial Visit Plus Follow-up	20
Skin Tag Removal Initial Visit Plus Follow-up	0
Skin Tag Removal Initial Visit Plus Follow-up	0
Skin Tag Removal Initial Visit Plus Follow-up	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.