Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons (Skin Tags)
Phase: NA
Conditions: Achrochordon
Sponsor: UK Innovations GP LTD

 
 
 
Clinical Trial Protocol 
Title of study:  Skin Tag Removal Device; A Clinical Study to 
Determine Outcomes of Treating Adults with Acrochordons 
(Skin Tags) 
NCT06463613 
 
Date: 06/05/2025 

 
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Clinical Investigation Protocol 
 
Title:  
Skin Tag Removal Device; A Clinical Study to Determine 
Outcomes of Treating Adults with Acrochordons (Skin Tags) 
 
 
 
Protocol: 
UKI-001 
 
Sponsor: UK Innovations GP LTD 
 
Version:  
2      
 
Date: 
 
TBD      
 
      
 

 
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Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone 
other than the Sponsor, the Investigator Team, HRA, host organization, and members of the 
Research Ethics Committee and Regulatory Authorities unless authorized to do so. 
 
Trial Title:   
 Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating 
Adults with Acrochordons (Skin Tags) 
Protocol Number:  UKI-001 
Protocol Version:  2      
Protocol Date:  
TBD      
  
 
Protocol signature page 
The undersigned has read and understood the trial protocol detailed above and agrees to 
conduct the trial in compliance with the protocol. 
  
  
  
  
  
    
Principal Investigator Name 
(Please print) 
  
Principal Investigator Signature 
  
  Date 

 
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Summary of Changes 
 
Protocol Section 
Protocol Version 1 
Protocol Version 2 
Rationale 
Section 3.1-3.2, 4, 
6.2.1-6.2.3 
Use of micro STR 
on 2-4 mm skin 
tags 
Use of micro STR on 
approximately 4-6mm 
skin tags 
The micro STR band has not reached 
the desired level of efficacy on      2-
4mm skin tags per use under      
protocol version 1. The Sponsor 
recommends the use of a micro STR 
band to be placed on larger skin tags, 
4-6mm, where they may be more 
effective at restricting blood flow to 
the skin tag and removing the tag. .  
Section 6.2.4, 
6.2.6 
Daily eDiaries Day 
1-10 
Daily eDiaries at 
screening visit, Day 1-20 
An eDiary has been added to the 
screening visit to capture a photo of 
the skin tag at the time of banding. 
The number of daily diaries have 
been extended to 20 days to allow 
tracking for skin tags which may fall 
off after day 10.  
Section 6.2.4 
Virtual Visit 2 
window Day 5-8 
Virtual Visit 2 window 
Day 5-9 
Visit window was extended to allow 
for more time to conduct the visit 
with no impact to patient safety      
Section 6.2.4 
Virtual Visit 3 
window Day 11-14 
Virtual Visit 3 window 
Day 21-24 
The visit was moved to one day after 
the last daily diary completed by 
participants, which is now day 20 
under protocol version 2. 
Section 6.2.1 
6.2.1 Stratification 
schematic to 
reflect 1:1 ratio of 
micro:standard STR 
device type 
6.2.1 Stratification 
schematic to reflect 3:1 
ratio of micro:standard 
STR device type 
Due to      micro and standard 
devices not reaching desired level of    
success      in removing      skin tags 
for 2-4 and 4-6 mm, respectively, the 
new recruitment efforts will focus on 
large skin tags and use of the micro 
device only 
Section 4 
Indications for use 
statement per 
device type 
General indications for 
use statement to be 
determined upon 
completion of the study  
Indications for use have been 
updated to be determined upon 
competition of the study 
Section 6.2.1 
80% compliance 
for eDiary 
completion to 
participant payment of 
$10 per eDiary 
completed 
Participant compensation has been 
changed from overall compliance 
calculation to daily diary completion 

 
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receive $100 
payment  
to increase retention & eDiary 
completion through Day 20      
Sections 6.2.3; 
6.2.6  
Rebanding not 
permitted; 
participants were 
withdrawn if device 
detached 
prematurely. 
Participants may 
receive up to two 
rebanding visits per skin 
tag at the site in the 
event of premature 
device detachment. 
Rebanding details (e.g., 
timing, outcome) will be 
captured in the eDiary. 
To allow controlled reapplication of 
the device and preserve participant 
data in cases of device failure, while 
maintaining consistency in study 
execution and analysis. 
Section 6.2.3  
No bandage was 
used after device 
placement. 
A small adhesive 
bandage is applied at 
the screening visit to 
cover the banded skin 
tag. Participants receive 
approximately 20 
bandages and 
instructions for 
replacement as needed. 
To reduce risk of premature band 
detachment due to friction from 
clothing and improve retention of the 
device throughout the study period. 
Section 6.2.1 
No guidance on re-
enrollment of prior 
participants 
Participants previously 
enrolled may be re-
enrolled if a different, 
previously unbanded 
skin tag is selected 
To allow enrollment of individuals who 
meet inclusion criteria and had a 
device failure in a prior protocol 
version, without compromising data 
integrity 
Sections 6.1, 14 
The observed 
percentage of 
successful removal 
is 80% 
The observed 
percentage of 
successful removal is 
60% 
Updated to reflect realistic 
expectations of effectiveness in a 
real-world setting. 
Section 11.2 
Not included 
New section on 
withdrawal for non-
compliance (e.g. missed 
rebanding) 
Ensures clear criteria for withdrawal 
tied to study adherence. 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
 
1. SPONSOR CONTACT INFORMATION 
4 
Sponsor Primary Contact 
4 
2. SUMMARY AND BACKGROUND INFORMATION 
4 
2.1. Skin tag background 
4 
2.2. Purpose of Investigative Study 
5 
3. STUDY DEVICE NAME AND DESCRIPTION 
5 
3.1. Study Device Name: Skin Tag Remover (STR) 
5 
3.2. General Description of Study Device 
6 
3.2.1. Device Kit Description 
6 
4. INDICATIONS FOR USE STATEMENT 
6 
5. REPORT OF PRIOR TESTING 
7 
6. INVESTIGATIONAL PLAN 
7 
6.1. Purpose and Study Arms 
7 
6.2. Study Design 
9 
6.2.1. Recruitment Population 
9 
6.2.2. Inclusion/Exclusion Criteria 
10 
6.2.3. Study Procedures 
12 
6.2.4. Schedule of Events 
13 
6.2.5. Medical Expenses and Clinic Visits 
14 
6.2.6. Clinical Endpoints 
15 
7. INVESTIGATIONAL SITE MONITORING 
19 
7.1. Direct Access to Source Data/Documents 
19 
7.2. Monitoring 
19 
8. DEVICE ACCOUNTABILITY 
19 
9. ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE MALFUNCTIONS 
20 
9.1. Adverse Event (AE) 
20 
9.2. Adverse Device Effect (ADE) 
20 
9.3. Serious Adverse Event (SAE) 
20 
9.4. Causality or Association of the Device with an AE or SAE 
21 
9.5. Serious Adverse Device Event Expectedness 
21 
9.6. Device Deficiency 
21 
10. PROTOCOL DEVIATIONS 
22 
11. SUSPENSION OR PREMATURE CLINICAL INVESTIGATIONAL TERMINATION 
22 
11.1. Suspension or Termination for Participant Safety Reasons 
22 

 
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11.2. Communication to Participants 
23 
12. INVESTIGATOR INFORMATION 
23 
12.1. Investigator Information 
23 
12.2. Initial Clinical Trial 
23 
13. BIBLIOGRAPHY/FOOTNOTES 
24 
14. BIOSTATISTICIAN POWER ANALYSIS 
25 
1. 
SPONSOR CONTACT INFORMATION 
 
Sponsor 
 
 
 
Primary Contact 
UK INNOVATIONS GP LTD  
 
 
Mr. Brad Fox (consultant) 
Kemp House Suite S 
 
 
 
Fox 
Consulting 
Network, 
LLC 
152 - 160 City Road 
 
 
 
5369 
E. 
Wallace 
Ave. 
London  
 
 
 
 
Scottsdale, 
AZ. 
85254 
EC1V 2NX  
 
 
 
 
bradfoxaz@gmail.com 
United Kingdom 
 
 
 
623-824-9165 
 
2. 
SUMMARY AND BACKGROUND INFORMATION 
 
2.1. Skin tag background 
The occurrence of potentially life-threatening malignant neoplasia in the skin has focused the public 
to address skin abnormalities, especially when they deviate from the skin's normal appearance. This 
produces an opportunity for early detection, by the patient and their physician, of potentially 
dangerous neoplasms such as malignant melanoma, squamous cell cancer and a long list of other 
rare neoplasms. However, the vast majority of skin lesions are benign, prompting many individuals 
to pursue      options for the removal of lesions for cosmetic reasons.  
Common benign skin lesions include verruca, seborrhea     , keratoses, fibromas, histiocytomas 
(dermatofibromas), nevi and skin tags (acrochordons). A skin tag is a small outgrowth of epidermal 
and dermal tissue. Their size can range from one to several mm; usually flesh-colored and 
pedunculated (see Image 1)1. Skin tags are exceedingly common benign skin lesions with a reported 
prevalence of around 45-50% in the general population. Typically, they are small, soft, noncancerous 
fibromas or fibroepithelial polyps, bumps of tissue connected to the skin's surface by a narrow stalk. 
The color, texture, size, and width of the base can vary2.  
 
While the exact cause of skin tags is not known, they can be found around folds of the skin or where 
areas of friction from clothes occur. Elevated blood sugar and insulin are linked to higher prevalence, 
but the mechanism, in this case, is still unknown. Some skin tags can become irritated, the most 
common motivation for removing skin tags is cosmetic.     
 
 
 
 
 
Tags can be removed by a dermatologist using excision, cauterization, or cryosurgical means, but 
 
1  Image from product’s UK labeling 
2 My Face Aesthetics Clinic: Skin Tags  

 
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there is a      growing interest      in home-based methods. Some devices, such as cryo-based 
cauterization, have been cleared for marketing by FDA for “over-the-counter” (OTC) use and 
claimed acceptable removal levels.  
Patients are motivated to remove skin tags, but the health care infrastructure is often less interested 
because skin tags are benign, and the cost of a clinical intervention can be hard to justify, regardless 
of the psychological impact on the patient. Skin anomalies such as skin tags may strongly affect the 
patient's quality of life. Even slight changes in the skin may result in adjustments to social life, 
relationships, and even the ability to carry out daily tasks.  
Histologically, a skin tag shows localized hyperplasia of the dermis with loosely arranged collagen 
fibers and dilated capillaries and lymphatic vessels3, indicating that a skin tag is softer, more elastic, 
and about as vascularized as the surrounding skin. The epidermis can be slightly hyperplastic.  
The cellular characteristics of the skin tag are important from the point of view of removal by 
pressure at the base. Externally exerted pressure would result in little resistance from the tissue, and 
the vasculature would easily collapse. These lesions tend to be smaller. However, the presence of 
nevus cells and a firm connective tissue network may protect the vasculature at the base from 
pressure. These lesions are often larger, broader in base, and "dome-shaped" and exert more 
resistance to compression of the base.  
The current device and study are based upon the mechanism of action that includes an occlusion 
of the vasculature at the base. This action results in a necrosis of the skin tag. When occlusion of the 
base is complete, the necrosis leads to the tag simply falling off.  
 
2.2. 
Purpose of Investigative Study 
The aim of this study is to investigate the safety and effectiveness      of a mechanical device to 
remove skin tags in adults. The device utilizes the ligation method by applying a silicone band around 
the base of a skin tag, therefore restricting the blood supply, which is vital to its growth and survival. 
Because this method does not include freezing or burning of tissue in or around the skin tag, it could 
be considered less invasive and less risky than other options. 
A clinical validation study to demonstrate the safe and effective removal of skin tags will be 
completed under the direction of an investigator (dermatologist or other health care professional) 
led protocol. This study will assess the proportion of skin tags successfully removed within a 20-day 
period, and to evaluate associated safety outcomes. Adult (22 years and above) subjects fitting the 
inclusion/exclusion criteria will be recruited, given they have one or more skin tags consistent with 
device labeling. All subjects entering the clinical study will have the device applied by the healthcare 
professional and proceed through the study, recording their experience using an electronic clinical 
diary to collect data.  
Since this device is to be sold over-the-counter, evaluation of the subject’s self-selection and label 
comprehension abilities will be completed under a separate Human Factors and Usability study and 
is therefore not required in the scope of this clinical trial. 
 
3 UC Davis Dermatology Online Journal 

 
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3. 
STUDY DEVICE NAME AND DESCRIPTION 
 
3.1. 
Study Device Name: Skin Tag Remover (STR) 
For this Protocol, the study device will be referred to as “Skin Tag Removal” study device or “STR” 
study device. There are two versions of the STR study device, automatic and manual. Each version is 
also manufactured in two sizes which correspond to the size of the skin tag to be removed.  
Under protocol version 1, t     he smaller size (to be referred to as “micro” for the remainder of this 
document) is designed to be used with skin tags having a base measuring between 2–4mm. The larger 
size (to be referred to as “standard” for the remainder of the document) is to be used with tags having 
a base measuring between 4–6 mm.  
Under protocol version 2, the micro size band will be used on all skin tags measuring between 4-6mm. 
The standard size will no longer be used and skin tags measuring between 2-4mm will not be enrolled.  
 
Product labeling has a helpful guide for determining size of band to use. All four versions function in 
the same manner by placing a band at the base of the skin tag, therefore, this document will 
collectively refer to all four iterations of the study device as “STR.” 
 
3.2. 
General Description of Study Device 
The STR study devices are designed for the removal of skin tags from the body by ligation of the 
blood supply to the skin tag through the application of a small elastic band. Bands are placed around 
the base of the skin tag by using an applicator, which pushes the band from a cylindrical extension 
on the device over the skin tag and to the base of the tag.  
The study device(s) are available in two different sizes to ensure the bands being used are tight 
enough to restrict the blood supply for skin tags that vary in size4.  
● Under protocol version 1: The micro version of the STR study device has been designed to 
remove skin tags that measure 2-4mm at the base, and the standard version is designed to 
remove skin tags that measure 4-6mm at their base. When determining band size, it is 
suggested to use the smaller (micro) device for tags that are in-between micro and standard 
for best results.  
● Under protocol version 2: Tthe micro size will be used on skin tags that measure 4-6mm at 
their base. The standard size will not be used. Additional Skin tags measuring 2-4mm will not 
be enrolled. 
 
4 Image from product’s UK labeling 

 
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For general information about this device, currently sold in the UK, please reference  
https://tagband.co.uk.  
 
3.2.1. Device Kit Description 
The STR study device(s) for this study are provided in kits containing:   
● STR study device 
● Band loader  
● Ten (10) bands 
● Isopropyl alcohol (70%) cleansing swabs (4) – used to cleanse the skin tag and surrounding 
area before applying the band 
 
In addition to the study device kits, the site will receive packages of ~30 bandages for each skin tag 
expected to be included in this study. These bandages will be provided to the participant at their 
in-clinic Baseline Visit.  
 
4. 
INDICATIONS FOR USE STATEMENT 
 
Micro Versions - Manual and Automatic: The STR device is indicated for the OTC treatment/ removal 
of skin tags with a diameter of 2-6     mm at the base. Use of the device will be restricted from skin 
tags in sensitive areas of the body such as on eyelids, near the eye, or in the groin area. The STR device 
is for use by adults 22 years of age or older.     Micro Versions will now be used on all skin tags with a 
diameter of 4-6mm at the base under protocol version 2. Skin tags measuring 2-4mm will no longer      
be enrolled.   
 
Standard Versions - Manual and Automatic: The STR device is indicated for the OTC treatment/ 
removal of skin tags with a diameter of 4-6mm at the base. Use of the device will be restricted from 
skin tags in sensitive areas of the body such as on eyelids, near the eye or the groin area.  It is for use 
by adults 22 years of age or older.       Standard versions will not be used under protocol version 2.  
 
The statements above were only the intended Indications For Use of the STR Device.  
 
Instructions For Use documents are provided to the Investigator for each study device and size. 
 
5. 
REPORT OF PRIOR TESTING  
 
The STR study device has been designed and manufactured following ISO13485 Quality Management. 
Sponsor management has implemented a Quality Management System during the design of the 
device and followed it through manufacturing. Failure modes for design/production (DFMEA and 

 
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PFMEA) processes have been completed and evaluated and are a part of the Design History File 
(DHF). 
 
In preparation for clinical testing, the STR study devices have completed testing regimens to 
document conformity to normalized standards, including ISO-10993 Biocompatibility. Biological 
testing for this device was completed in 2022 and a Biological Evaluation Report is available for review 
by contacting the Sponsor. 
 
6. 
INVESTIGATIONAL PLAN 
The Sponsor has developed the following investigational plan to clinically evaluate the safety and 
efficacy of the STR study device to remove skin tags from adult participants. 
 
6.1.  Purpose and Study Arms 
 
This pivotal investigational study is designed to evaluate the safety and efficacy of a skin tag removal 
(STR) study device. This is a non-significant risk interventional clinical study that will be conducted 
by a Clinical Research Organization (CRO) with a licensed dermatologist(s) to serve as Principal 
Investigator. There are two arms of the study that are only differentiated by the type of STR study 
device used; arm 1 will be conducted using the manual version, and arm 2 will use the automatic 
version.  
 
After consultation with the FDA, the Sponsor has modified the original protocol to include the 
following changes: 
 
● Exclusion of all skin tags located around the eye, on the eyelid, or the groin area (6.2.1) 
● Clarification of covered medical expenses while enrolled in the study (6.2.4) 
● Protocol includes updated exclusion conditions (excluding those with known hypertrophic 
scarring or keloid scarring) 
● Protocol includes the addition of an electronic daily diary for all participants 
● A study was conducted to power the investigation for biostatistical relevance properly (please 
see the report in the Reference section). The conditions for power analysis were:  
 
o 
The primary endpoint is the removal of the skin tag (effectiveness) 
o 
The observed percentage of successful removal is 60%; i.e. 60% of the skin tags treated are 
expected to be successfully removed with use of the device 
o 
A 95% Confidence Interval (CI) was used to determine the number of subjects necessary for 
participation 
 
Determination: if a successful clinical trial is established at 60% of treated skin tags removed, a study 
powered with 200 treated tags will have a 95% confidence interval of 5.5% 
 

 
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The power analysis determined that the sponsor should enroll enough subjects to treat a total of 200 
skin tags. Typically, patients seeking skin tag removal have from 1 to 5 tags that could be treated for 
removal, however, for this study, only a maximum of 2 tags per person will be treated. Therefore, the 
number of tags for intention to treat (ITT) in each arm is 100 for a study total of 200 tags. This 
approach will ensure that the study has been powered to a 95% confidence interval of 5.5%. 
Approximately two thirds of the subjects in each arm are to receive micro bands (2-6 mm skin tags 
treated), while the other one third is to receive standard size bands (4-6mm size skin tags treated). 
The PI will manage the number of treated skin tags such that a variety of locations on the body (face, 
neck, arms, and torso) are represented in the study. 
Under Protocol Version 1: 
Arms 
Assigned Interventions 
Arm 1 – Manual Version 
Goal: successful removal of 60% of the skin tags 
treated with the STR device. Subjects will have up 
to two (2) tags treated, therefore, 50-100 
subjects are anticipated for this arm. A total of 
100 skin tags is the ITT (intention to treat). 
Subject treatment data collected on: 
● Band size; 2-4mm (micro), or 4-6mm (standard) 
● Subject pool divided ~equally by band size 
● All skin tags will be banded by a healthcare 
professional 
Arm 2 – Auto Version 
Goal: successful removal of 60% of the skin tags 
treated with the STR device. Subjects will have up 
to two (2) tags treated, therefore, 50-100 
subjects are anticipated for this arm. A total of 
100 skin tags is the ITT (intention to treat). 
Subject treatment data collected on:  
● Band size; 2-4mm (micro), or 4-6mm (standard) 
● Subject pool divided ~equally by band size 
● All skin tags will be banded by a healthcare 
professional       
 
Under Protocol Version 2: 
 
Arms 
Assigned Interventions 
Arm 1 – Manual Version 
Goal: successful removal of 60% of the skin tags 
treated with the STR device. Subjects will have up to 
two (2) tags treated, therefore, 50-100 subjects are 
anticipated for this arm. A total of 100 skin tags is the 
ITT (intention to treat). 
Subject treatment data collected on: 
● 
Tag size; 4-6 mm (micro band)           
● 
All skin tags will be banded by a healthcare 
professional 

 
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Arm 2 – Auto Version 
Goal: successful removal of 60% of the skin tags 
treated with the STR device. Subjects will have up to 
two (2) tags treated, therefore, 50-100 subjects are 
anticipated for this arm. A total of 100 skin tags is the 
ITT (intention to treat). 
Subject treatment data collected on:  
● 
Tag size; 4-6     mm (micro band      
● 
All skin tags will be banded by a healthcare 
professional licensed dermatologist 
 
For subjects meeting the inclusion/exclusion criteria and entering the study and having two skin tags 
being treated as a part of this study, please see the study design details on how both skin tags are to 
be treated in Section 6.2 below. 
 
6.2. Study Design 
This protocol was developed after consultation with the FDA under a Q-submission, Q222756, where 
it was determined to be a non-significant risk trial.  
 
6.2.1. Recruitment Population  
For both arms of the study, subjects located in the U.S. will be recruited from the general population 
and/or through an invitation presented by the Principal Investigator or CRO. Potential participants 
may self-complete an IRB-approved online pre-screening survey. Every effort will be made to 
recruit well-represented subjects from the following groups: 
● Age (22-50 and 51+)  
● Sex assigned at birth (M/F) 
● Race/Ethnicity 
● Fitzpatrick Skin Type 
The study cohort target is between 30 and 70 subjects per arm (depending on how many skin tags 
each subject presents for treatment), as determined by the power analysis.       
Under Protocol Version 1, the study included two arms (manual and automatic STR application), and 
participants were treated with either the micro (2–4mm) or standard (4–6mm) sized band depending 
on the measured base width of the skin tag. Each arm included a roughly equal number of tags treated 
with each device size. 
It is anticipated that some subjects will likely have several skin tags that could be treated with the 
STR study device. A maximum of two skin tags per subject may be chosen for treatment. For purposes 
of pooling the data more effectively, if a subject opts to have two skin tags treated in the study, the 

 
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following must apply; 
● 
both skin tags must be of the same size; either micro (2-4mm); or standard (4-6mm).  
U     nder protocol version 2, only skin tags measuring between 4-6mm will be banded 
with the micro size.  
● 
both skin tags must be treated in the same arm (e.g. using the same STR study device, 
manual or automatic) 
● 
skin tags must be in two different, distinguishable locations on the body (i.e. right side of 
neck and left armpit) 
As of Protocol Version 2, only skin tags measuring 4–6mm at the base will be eligible for enrollment, 
and only the micro version of the STR device will be used. The standard-sized band will no longer be 
used in this version of the study. Participants may still have up to two eligible skin tags treated, 
provided both are within the 4–6mm size range, in different anatomical locations, and treated using 
the same device arm (manual or automatic). 
Participants previously enrolled under an earlier version of the protocol may be eligible to reenroll, 
provided a different, previously unbanded skin tag(s) is selected for treatment. Skin tags previously 
banded are not eligible for rebanding under this protocol version. 
Therefore, the total intention to treat (ITT) is 200 skin tags for arms 1 and 2 combined. If the study is 
completed with subjects only having one skin tag treated, then the study would need to recruit 200 
subjects. If each subject had two skin tags treated, only 100 subjects would need to be recruited. It 
is anticipated that between 100 and 200 subjects will be required to treat a total of 200 skin tags.  
The figures below depict how the total subject pool would be divided into the two arms under both 
versions of the protocol, where “N” is the number of subjects: 
Under Protocol Version 1: Figure 1 
 
Figure 1: Breakdown of subjects into each arm and size of band used to be stratified as equally as possible in the 
targeting of ~200 treated skin tags.  
 

 
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Under Protocol Version 2: Figure 2 
 
Figure 2: Breakdown of subjects into each arm to be stratified as equally as possible in the targeting of ~200 treated 
skin tags.  
 
Once enrolled in the study, the Investigator will assign an STR version for use (manual/ automatic     . 
Only the micro-sized band will be used in this version of the protocol, and only skin tags measuring 
4–6mm at the base will be eligible for treatment. The Investigator will also review the subject’s skin 
tags and agree with the subject on the body location and skin tag(s) that will be treated (see exclusion 
criteria)     . The Investigator will also verify that the skin tag does not present a morphology 
representing implications of cancerous tissue. After signing informed consent and reviewing device 
lab,eling as well as determining eligibility     , the subject will then have the band(s) placed on the skin 
tag(s) by the healthcare professional.  
Once the band has been placed, the Investigator will examine the skin tag, complete study 
documentation, and answer any questions or concerns the subject has regarding the device or 
procedure. A small adhesive bandage will be placed over each treated skin tag immediately following 
banding. The subject will then review trial diary instructions, including but not limited to the 
documentation of all observable characteristics regarding the banded skin tag(s). The subject will 
complete their first eDiary at the visit including photo upload(s) of the banded skin tags. They will 
continue eDiary completion every evening starting at Day 1 through Day 20. This diary is electronic 
(eDiary) and accessed through the CRO’s secure website. All subjects must be able to access the 
eDiary via smartphone to participate in the study, as defined in the informed consent.  per day for 
eDiary completion, up to a maximum of $200.      

 
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6.2.2. Inclusion/Exclusion Criteria 
Enrollment in the study will be limited to participants who meet all of the following inclusion criteria 
and none of the exclusion criteria: 
Inclusion Criteria 
1. Adults at least 22 years of age.  
2. Must be able to understand, speak, and read English sufficiently for completion of the 
trial. 
3. Subject has at least one skin tag meeting ALL of the following requirements: 
a. no previous attempts to remove the skin tag(s) of investigation, including skin 
tags that were treated in a previous version of this protocol  
b. measuring between 4     mm and ~6mm at the base. S     kin tags measuring larger 
than 6mm can be rounded down based on investigator’s discretion.   
c. not located around the eye, on the eyelid, or in the groin area  
d. if treating two tags, only one may be located in axilla 
e. free of any active skin infection & area to treat tag has no severe eczema 
f. 
located in an area where participant can take a self-taken photo  
g. does not, in the opinion of the Investigator, require an evaluation by pathology at 
the time of screening 
4. Subject has access to the internet via smartphone to complete the eDiary. 
 
Exclusion Criteria 
1. Significant medical condition or other circumstance which, in the opinion of the 
Investigator, would preclude compliance with the protocol, adequate cooperation in the 
trial or providing informed consent, or may prevent the subject from safely participating 
in the trial 
2. Any prior history of skin-related cancer 
3. Subject states that they are currently pregnant or intending to become pregnant during 
the course of the study 
4. Has an allergy to latex 
5. Current diagnosis of a bleeding disorder included but not limited to Hemophilia or Von 
Willebrand disease 
6. Currently being treated with blood thinners (use of 81 mg of Aspirin is not exclusionary) 
7. Currently being treated with topical steroids at site of skin tag of interest or oral 
steroids 
8. Currently immunocompromised by conditions such as diabetes (either Types 1 or 2, 
regardless of level of control) or receiving immunosuppressant therapy 
9. Current MRSA infection 
10. Diagnosis or any history of keloid or hypertrophic scarring 

 
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11. Current or recent participation within the last 30 days in another interventional clinical 
trial 
 
6.2.3. Study Procedures 
 
Demographics  
Participants will provide demographic information at the baseline visit. They will provide a full date 
of birth (for the calculation of age), gender, and race/ethnicity. 
 
Medical History  
A verbal medical history that provides specific information regarding inclusion and exclusion 
(eligibility) criteria will be taken at screening including diagnoses and surgical procedures within the 
last 6 months. 
 
Concomitant and Prohibited Medications 
Investigator to review & document all current concomitant medications at day of screening and 
confirm eligibility per inclusion/exclusion criteria.  
 
While enrolled in the study, participants should refrain from starting any anticoagulants, 
immunosuppressive therapies, oral steroids, or topical steroids applied near the area of the banded 
skin tag.  
 
The use of a daily 81mg Aspirin is allowed, but note that this is a concomitant medication of interest 
and may increase bleeding and/or delay healing. 
 
 
Modified Fitzpatrick Skin Type 
Study team will administer to each participant who self-reports where their skin falls on the 
Fitzpatrick scale of burn versus tan with the ranking of I through VI. 
 
 

 
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Image 5: Fitzpatrick Skin Type Chart 
 
Limited Dermatological Exam 
Investigator to examine potential skin tags to determine eligibility per inclusion criteria. Skin tag(s) 
will be measured and recorded.     . No further dermatological exam to be performed.  
 
Device Use and Band Application 
The Investigator will complete training on device use for both automatic and manual options. Once 
a participant has met all inclusion and no exclusion criteria, the Investigator will apply the      band(s) 
to the selected skin tag(s) and record location. Under protocol version 2, skin tags measuring 
between 4-6mm will all be banded using the micro size. The Investigator      will place an adhesive 
bandage over each skin tag, following band application to prevent premature device detachment 
due to friction with clothing. Participants will receive a supply of bandages with their study kit, along 
with instructions for daily bandage removal and replacement for photo documentation. For those 
with two skin tags using the STR device, it is important to note which tag will be designated as #1 
and which will be designated as #2 for eDiary reporting. 
 
In the event of premature device detachment, the participant will note a detachment event in their 
daily eDiary. They will be instructed to contact the site to schedule a reapplication by the 
Investigator. The same device kit and application method (Auto or Manual) will be used for each 
rebanding. No more than two rebandings per skin tag will be permitted. The timing of rebanding, 
including the interval between band loss and reapplication, will be captured in the eDiary system.  If 
a participant is unable to schedule a rebanding visit within 3 business days, they may be withdrawn 
from the study. 
 
6.2.4. 
Schedule of Events 
Potential participants may self-complete an IRB-approved online pre-screening survey. Those 
eligible based on survey responses will meet with the study team & Principal Investigator for the 
screening and baseline visit. If the subject agrees to take part in the study, they must read and sign a 
consent form, which will include the Inclusion/Exclusion criteria, information on completing the study 

 
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diary electronically as well as the covered medical expenses by the clinical study (see 6.2.5).  
 
 
Schedule of Events 
 
 
Pre-Screening 
Phase 
Treatment Phase 
Post-Treatment 
Unscheduled 
 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Unscheduled 
Visit Type 
Pre-Screening  
Screening/ 
Baseline 
Follow-Up 
Follow-Up 
End of Study 
Unscheduled 
Visit Location 
(virtual) 
(in clinic) 
(virtual) 
(virtual) 
(virtual) 
(in clinic) 
Window 
(-42 to Day 1) 
Day 1 
Days 5-9      
Days 21-24     
Days 30-37 
N/A 
Procedure 
 
 
 
 
 
 
Pre-Screening Survey 
X 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
Demographics 
 
X 
 
 
 
 
Medical History 
 
X 
 
 
 
 
Concomitant Medications 
 
X 
X 
X 
X 
 
Modified Fitzpatrick Skin Type 
 
X 
 
 
 
 
Limited Dermatological Exam  
 
X 
 
 
 
X 
Eligibility Determination 
 
X 
 
 
 
 
Device Use/ Band 
Application4 
 
X 
 
 
 
 
Band Re-application(s) 
 
X5  
 
 
eDiary Training 
 
X 
 
 
 
 
eDiary/Photo Review 
 
x 
X 
X1 
X2 
 
Adverse Events 
 
X 
X 
X 
X 
X 
Surgical Excision  
 
 
 
 
 
X3 
1 if treated skin tag(s) has/have not fallen off by Visit 3, participant has option to have skin tag(s) removed at an Unscheduled Visit by calling the  
Investigator’s office and making an appointment 
2 no eDiary entries for this visit; only photo(s) to be submitted by participant and reviewed by Investigator to confirm coordinator may exit participant  
from study. If Investigator has concerns about participant’s D30 photo, participant will have an Unscheduled Visit for examination 
3 optional: presented to subject in the event the skin tag was not removed by STR study device by D10 
4 Participants will complete the initial eDiary and photo(s)  upload at the Day 1,  in-clinic visit. 
5 Band -Repplication to be performed by PI or Sub-I as needed at the site in the event of the band falling off. Participants will be allowed 2 re-
applications per skin tag throughout the course of the study.  

 
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6.2.5. Medical Expenses and Clinic Visits 
Certain medical expenses will be covered during the study by the Sponsor. These include the 
following: 
● 
investigational device costs 
● 
clinical care costs for the placement and follow-up of the investigational device 
● 
clinical care costs to remove skin tag in the event of failed treatment by device 
o removal of skin tag via surgical excision if STR device unsuccessful 
● 
up to 2 on site rebanding visits in instances of premature band detachment 
● 
clinical care costs relating to the following adverse event when using the device: 
o infection of the skin tag site 
 
The following medical expenses will NOT be covered;  
● 
cosmetic treatment related to pigment change or minor scarring at the skin tag site 
● 
treatment related to hypertrophic scarring and/or keloids (subjects with these prior to 
consenting are excluded from study participation) 
 
The study subjects will have access to a healthcare professional at the Investigator’s clinic, including 
a 24-hour number to contact the investigator. If at any time the subject is concerned about treatment 
complications, they shall contact the PI immediately. An unscheduled visit may be performed.     
 
6.2.6. Clinical Endpoints 
 
Primary clinical endpoints and data collected are defined as follows: 
Primary 
Outcome 
Time Frame 
Description and Data Collected 
Successful 
removal of 
acrochordons 
using the STR 
device 
Visit 1: subject 
screening and band 
placement 
(in-clinic) 
● Obtain subject’s informed consent 
● Study team member to verify inclusion/exclusion criteria 
● Identification of skin tag(s) to be used in study, including size 
(micro or standard) and location 
● Documentation of body location and number of tags 
● Investigator to stratify subject into either manual or automatic 
device arm 
● Placement of band(s) by Investigator 
● Placement of bandage(s) by investigator 
● Subject to read after-care instructions & review any questions 
with study team  
● Subject will receive clinical eDiary instructions comprising of 
device use, comprehension, and adverse events and later 
complete Day 1 entry  
● Subject will upload a photo of the banded skin tag(s) in clinic 

 
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during Visit 1, which will be reviewed by the site staff 
● Study team member to remind subject that an in-clinic visit is 
always available upon request and to call with any questions or 
concerns 
● Study team member to remind subject to schedule an in-clinic 
rebanding visit at their earliest convenience in the event of 
premature band detachment 
Visit 2 
(virtual) 
At Visit 2, the subject is to complete a remote visit where the 
following activities are performed:  
● Subject and study team member will review the photos and 
verify eDiary compliance for all days up to Visit 2 and also 
identify any signs of infection, irritation, or other adverse events 
● Study team member to record general observations of tag(s) 
treated, flagging any concerns to Investigator 
● Study team to review any instances of premature band 
detachment, and to remind participant to schedule a rebanding 
visit if not already completed 
● Subject to continue filling out eDiary through Day 2     0 
regardless if skin tag(s) remain(s) 
● Study team member to review after care instructions that are 
to be followed through Visit 4 
● Study team member to remind subject that an in-person visit 
is always available upon request and to call with any questions 
or concerns 
Visit 3 
(virtual) 
At Visit 3, the subject is to complete a remote visit where the 
following activities are performed:  
● The subject and study team member will review the eDiary and 
photos to verify completion through day 2     0 
● Subject to report any signs of infection, irritation, and adverse 
events to study team member. Subject should also provide 
information in eDiary identifying these issues 
● Ensure recording of successful removal of the skin tag via STR 
study device (if applicable) 
● Study team member and subject to review after care 
instructions to be followed through Visit 4 
● If skin tag has not fallen off, study team member to discuss the 
following options with subject: 
o If subject wants skin tag to be removed, study team member 
instructs them to call Investigator’s office for an 
Unscheduled Visit to have skin tag removed by Investigator 

 
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o If subject is not interested in skin tag removal by 
Investigator, study team member instructs them to follow 
directions provided on After Care Instructions on proper 
self-removal of the band around treated skin tag 
● Study team member to remind subject that an in-clinic visit is 
always available upon request up to Visit 4 and to call with any 
questions or concerns 
 
 
 

 
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Secondary clinical endpoints and data collected are defined as follows: 
Secondary 
Outcomes 
Time Frame 
Description and Data Collected 
Discomfort, 
issues, or adverse 
events occurring 
during the study 
Visit 2 
(virtual) 
The subject is to complete a virtual visit where the following activities 
are performed:  
● General observations, as described by the subject, of the skin tag 
site  
● Review photos uploaded to eDiary and discuss any issues with 
irritation, infection, or other adverse events 
● Study team to review any instances of premature band 
detachment, and to remind participant to schedule a rebanding 
visit if not already completed 
● Study team member to record and report any safety-related 
issues regarding irritation or infection to Investigator 
● Remind subject to continue daily recordings in  eDiaryto remain 
in study  
● Study team member to review AEs and Concomitant 
Medications at virtual visit 
● Study team member to remind subject that an in-clinic visit is 
always available upon request and to call with any questions or 
concerns 
Visit 3 
(virtual) 
The subject is to complete a virtual visit where the following activities 
are performed:  
● General observations, as described by the subject, of the skin tag 
site.  
● Review photos uploaded to eDiary and discuss any issues with 
irritation, infection, or other adverse events 
● If skin tag(s) has/have not been removed by STR study device, 
study team member to review options with subject for tag 
removal.  
o 
If subject wants skin tag to be removed, study team 
member instructs them to call Investigator’s office for 
an Unscheduled Visit to have skin tag removed by 
Investigator 
o 
If subject is not interested in skin tag removal by 
Investigator, study team member instructs them to 
follow directions provided on After Care Instructions 
on proper self-removal of the band around treated 
skin tag 
● Study team member to review AEs and Concomitant 
Medications at virtual visit 
● Study team member and subject to review After Care 
Instructions that are to be followed until Visit 4 (and beyond if 

 
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necessary). 
 
Study team member to remind subject that an in-clinic visit is always 
available upon request, up to Visit 4, and to call with any questions or 
concerns 
Visit 4 
(virtual) 
The subject is to complete a remote visit where the following 
activities are performed:  
● Photo submission(s) of skin tag site(s) approximately 30 days 
(but not earlier than Day 30) after band(s) was/were placed 
● Investigator will review photo(s) and verify the subject is either 
cleared to exit study or needs to return to clinic for an 
Unscheduled Visit 
● Study team member to review AEs and Concomitant 
Medications at virtual visit once subject is cleared to exit study 
by Investigator 
 
6.2.6.1. 
Reported Post Study Data  
Case Report Forms will be used by the CRO to collect and organize data. All data collected during 
the investigational study will be compiled by the CRO and securely stored by the Sponsor. Data 
collected will be captured and archived using a per-protocol approach. 
The following table provides a list of the reported primary outcomes, as evidenced by the study. 
Data subgroup analysis following the completion of the study and performance data analysis 
reported by: 
● Age (22-50 vs. 51+) 
● Sex assigned at birth (M/F) 
● Band size (micro vs. standard) 
● Band detachment events, including duration of detachment 
● Body location of band placement 
● Mechanism of device used (automatic vs. manual) 
 
Data Collected 
Description 
Proper band placement 
Source: Visit 1, Investigator Records 
STR study device bands will be placed on up to two (2) skin tag(s) by t   
he Investigator.      
Source: eDiary 
Participant will upload a photo(s) of the banded skin tag(s) in the eDiary 
at the Visit 1 in-clinic visit.  

 
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Efficacy of skin tag 
removal 
Source: Days 2-2     0, Case Report Forms and Subject eDiary 
The total number of skin tags treated and those successfully removed 
by use of the STR study device will be compiled and reported. 
In all cases, the removal rate will be categorized by skin tag size (micro 
or standard) and body location as well as subject demographics 
Safety and Potential 
Health Impacts 
Source: Case Report Forms and Subject eDiary 
There are not any serious adverse effects anticipated with this study; 
potential non-serious side effects during the use of the STR study 
device are as follows and will be collected: 
● 
Irritation  
● 
Tenderness 
● 
Pigment change 
● 
Scarring 
Less common but potential side effects that need to be collected and 
addressed are: 
● 
Infection 
● 
Redness or swelling at the base of tag 
● 
Bleeding 
● 
Pain  
● 
Delayed healing (greater than 14 days after tag falling off/removal) 
● 
Hypertrophic or Keloid scarring 
● 
Other (as defined/described in the eDiary manual) 
General use comments by the subjects, including photos depicting the 
progression of the skin tag(s) treatment and after the tag has fallen off. 
Only adverse events associated with the device will be recorded and 
documented as Adverse Device Effects (ADEs). 
 
7. 
INVESTIGATIONAL SITE MONITORING 
 
7.1. Direct Access to Source Data/Documents 
Sponsor or agents of sponsor, the reviewing IRB/EC, and health authorities from the US or other 
countries will have access to source documents at the investigational site for monitoring, auditing 
or inspection purposes.  
 
7.2. Monitoring 
Details of planned monitoring for the trial may be found in a Site Monitoring Plan developed prior to 
the start of the trial.  
 
8. 
DEVICE ACCOUNTABILITY 

 
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The investigational devices shall be securely maintained, controlled, and used only in this clinical 
trial. The sponsor shall keep records to document the physical location of all investigational devices 
from shipment of investigational devices from designated facility/equipment to the investigation 
site until return or disposal. 
Records shall be kept by the investigation site to document the physical location and conditions of 
storage of all investigational devices. 
The Principal Investigator or an authorized designee shall keep records documenting the receipt, 
use, and disposal of the investigational devices, which shall include the following: 
● Date of receipt 
● Identification of each investigational device (unique code) 
● Expiry date, as applicable 
● Date on which the investigational device was dispensed and to which participant  
● Date of disposal for all used devices 
● Date of disposal for unused, expired, or malfunctioning investigational devices, if applicable 
Standard size kits used under protocol version 1     l will      not be used under      protocol version 2. 
 
9. 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE 
MALFUNCTIONS 
 
9.1. Adverse Event (AE) 
 
An Adverse Event is defined as untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in participants, users, or other 
persons, whether or not related to the investigational medical device and whether anticipated or 
unanticipated.  
For the purpose of this study, the only AEs to be collected are Adverse Device Effects (ADE) as 
mentioned in section 9.2 and Serious Adverse Events mentioned in Section 9.3. 
 
9.2. Adverse Device Effect (ADE) 
 
An Adverse Device Effect is an AE related to the use of an investigational medical device. For this 
study, the following ADEs will be collected if they occur at the location of the skin tag removal band 
placement including, but not limited to: 
● Irritation 
● Pain 
● Bleeding 
● Infection 
● Hypertrophic or keloid scarring 

 
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● Prolonged healing, defined as the healing process taking longer than 14 days after the tag has 
fallen off or been removed by the Investigator 
● Any other symptom or abnormality that led to permanent discontinuation of the trial device. 
 
These events will be rated a mild, moderate or severe intensity using the following definitions: 
Mild: Mild events are usually transient and do not interfere with the Participant’s daily activities 
 
Moderate: Moderate events introduce a low level of inconvenience or concern to the Participant 
and may interfere with daily activities. A medication may be necessary. 
 
Severe: Severe events interrupt the Participant’s usual daily activity 
 
9.3. Serious Adverse Event (SAE) 
 
A serious adverse event is any adverse event that leads to: 
a) death 
b) serious deterioration in the health of the subject , users, or other persons as defined by one 
or more of the following: 
a. a life-threatening illness or injury, or 
b. a permanent impairment of a body structure or a body function including chronic 
diseases, or 
c. in-patient or prolonged hospitalization, or 
d. medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function; 
e. fetal distress, fetal death, a congenital abnormality, or birth defect including physical 
or mental impairment.  
Serious adverse events must be reported to the sponsor within 24 hours of coming to the 
investigator's attention. Any serious adverse event that occurs any time after the participant has 
signed the informed consent form for the trial, up to the Participant’s final trial visit, inclusive, is to 
be reported through the EDC within 24 hours following when the event was first recognized, 
discovered, or reported, regardless of severity or relationship to the trial device.  
The investigator is to also notify the IRB/EC of the serious adverse event promptly, and according to 
IRB/EC requirements.  Documentation of the serious adverse event reports (using Form FDA 3500A 
or equivalent) should be submitted to Lindus Health at skintag@lindushealth.com.  Documentation 
is to be kept in the investigational site’s trial files and is to be checked routinely by the clinical 
research associate (CRA). 
After receipt of a serious adverse event report, the sponsor will notify all appropriate regulatory 
authorities as necessary, within the required time frames. Written safety reports submitted to 

 
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regulatory authorities will be completed by the sponsor with the assistance of the investigator and 
other site personnel as needed.  
Serious adverse events must be followed up by the investigator until resolution or stabilization.  
 
9.4. Causality or Association of the Device with an AE or SAE 
When the device caused or was associated with an AE or SAE, the event is an Adverse Device Event 
(ADE), or Serious Adverse Device Event (SADE), respectively. 
 
9.5. Serious Adverse Device Event Expectedness 
A SADE may be anticipated, an anticipated serious adverse device event (ASADE), or unanticipated, 
an unanticipated serious adverse device event (USADE). 
Unanticipated serious adverse device events (USADEs) require expedited reporting to health 
authorities. 
 
9.6. Device Deficiency 
A device deficiency is a failure of the device to meet requirements for identity, quality, durability, 
reliability, usability, safety, or performance.  
Device deficiencies should be documented by the investigator using Form FDA 3500A or equivalent. 
Form should be submitted to skintag@lindushealth.com. Documentation is to be kept in the 
investigational site’s trial files and is to be checked routinely by the clinical research associate (CRA). 
 
10. PROTOCOL DEVIATIONS 
A trial related deviation is a departure from the ethically approved trial protocol or other trial 
document or process (e.g. consent process or IMP administration) or from Good Clinical Practice 
(GCP) or any applicable regulatory requirements. Any deviations from the protocol will be 
documented in a protocol deviation form and filed in the trial master file. 
A Lindus Health SOP is in place describing the procedure for identifying non-compliances, escalation 
to the central team and assessment of whether a non-compliance /deviation may be a potential 
Serious Breach. 
 
11. SUSPENSION OR PREMATURE CLINICAL INVESTIGATIONAL 
TERMINATION 
 
A Investigator, IRB/EC, or regulatory authority may suspend or prematurely terminate participation 
in a clinical investigation at the investigation sites for which they are responsible.  

 
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Should the investigation suspend the trial or the reviewing IRB/EC withdraw the approval for a trial, 
the Investigator shall report the suspension or withdrawal to the sponsor within 24 hours.  
The sponsor may suspend the whole trial at any time for other reasons, but will document why. In 
the unlikely event this should occur, efforts will be made to allow already enrolled affected 
participants to complete their participation in the trial as planned. 
 
11.1. Suspension or Termination for Participant Safety Reasons 
In case of a USADE, the sponsor will suspend the trial immediately while analyzing available 
information for a decision about further action. Should less serious new information become 
available that change the benefit/risk balance in an unfavorable direction, the sponsor may suspend 
the trial immediately while analyzing available information for a decision about further action. 
 
11.2. Withdrawal Due to Participant Non-Compliance 
A participant may be withdrawn from the study at the discretion of the Investigator and/ or Study 
Team in the event of non-compliance with the study protocol. In particular, if the study device 
detaches prematurely and the participant fails to contact the site or schedule a rebanding 
appointment, the participant may be withdrawn from the study. Failure to comply with rebanding 
procedures may render the participant ineligible to continue in the study. 
 
All withdrawals and the reasons for withdrawal will be documented in the participant’s source 
documentation and eCRF, as applicable. 
11.3. Communication to Participants 
In case of suspension or termination the Investigator or other investigative staff communicates this 
to participants and makes arrangements for the completion and follow up. 
 
 
12. INVESTIGATOR INFORMATION 
 
12.1. Investigator Information 
A licensed dermatologist shall serve as Principal Investigator for this trial while supported by other 
qualified healthcare providers. All facilities participating in this trial, along with the names of every 
Investigator that will participate in and/or review the trial information, will be required to sign an 
Investigator Agreement in accordance with 21 CFR 812.43. The sponsor will collect this information 
as a condition of the facilities’ involvement and shall maintain copies with the rest of the study 
materials. 

 
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12.2. Initial Clinical Trial 
The sponsor has received feedback from the FDA that this investigational study is a non-
significant risk (NSR) device study, and therefore, a formal Investigational Device Exemption (IDE) 
application and approval are not required. However, the study is still subject to the FDA’s 
abbreviated requirements for device clinical studies. A Central IRB’s review of the protocol will be 
completed under the CRO’s contract. 
 
 
 
13. BIBLIOGRAPHY/FOOTNOTES 
  
1. “TagBand”.  UK Innovations GP LTD. 04 Mar 2024. https://tagband.co.uk.  
2. “Skin Tags”. My Face Aesthetics. 2017. http://www.my-face-aesthetics-clinic.co.uk/skin-
conditions/skin-tags.html. 
3. Fredriksson, Carina H; Ilias, Michail; Anderson, Chris. Dermatology Online Journal. 2009, Vol 15. 
https://escholarship.org/uc/item/7tj2800k. 
4. “TagBand”.  UK Innovations GP LTD. 04 Mar 2024. https://tagband.co.uk. 
5. Remulkar, Tanvi. “Do You Know Your Fitzpatrick Skin Type?” Food For Skin. 13Sep2021. 
https://foodforskin.org/know-your-skin-whats-fitzpatrick-skin-type/ 
 
 
 
 
 
 

 
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14. BIOSTATISTICIAN POWER ANALYSIS 
 
Confidence intervals were calculated based on the following specifications: 
 
1. 
Endpoint: Skin Tag Removal 
2. Observed percentage = 60%, 65%, or 70% 
3. Sample Size: 25, 50, 75, 100, 125, 150, 175, or 200 
4. Normal approximation 95% CIs 
The confidence intervals are presented in Table 1. 
 
Table 1: Confidence Intervals for Skin Tag Removal