AchrochordonNCT06463613
Using a Novel Skin Tag Removal Device
A study testing STR Skin Tag Removal device with diary and follow-up in people with Achrochordon, run by UK Innovations GP LTD at 1 site in United States.
Trial summary
The aim of this study is to investigate the use of a mechanical device to remove skin tags in adults. The device ("Skin Tag Removal", or STR) 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achrochordon
- What is being tested?
- STR Skin Tag Removal device with diary and follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults at least 22 years of age.
- Must be able to understand, speak, and read English sufficiently for completion of the trial.
- Subject has at least one skin tag meeting ALL of the following requirements:
- no previous attempts to remove the skin tag(s) of investigation, including skin tags that were treated in a previous version of this protocol
- measuring between 4mm and 6mm at the base. Skin tags measuring larger than 6mm can be rounded down based on investigator's discretion.
- not located around the eye, on the eyelid, or in the groin area
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- if treating two tags, only one may be located in axilla
- free of any active skin infection \& area to treat tag has no severe eczema
- located in an area where participant can take a self-taken photo
- does not, in the opinion of the Investigator, require an evaluation by pathology at the time of screening
- Subject has access to the internet via smartphone to complete the eDiary
Who cannot join
- 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
- Any prior history of skin-related cancer
- Subject states that they are currently pregnant or intending to become pregnant during the course of the study
- Has an allergy to latex
- Current diagnosis of a bleeding disorder included but not limited to Hemophilia or Von Willebrand disease
- Currently being treated with blood thinners (use of 81 mg of Aspirin is not exclusionary)
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- Currently being treated with topical steroids at site of skin tag of interest or oral steroids
- Currently immunocompromised by conditions such as diabetes (either Types 1 or 2, regardless of level of control) or receiving immunosuppressant therapy
- Current MRSA infection
- Diagnosis or any history of keloid or hypertrophic scarring
- Current or recent participation within the last 30 days in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
About this study
Official title: Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons (Skin Tags)
The aim of this study is to investigate the use of a mechanical device to remove skin tags in adults.
The device ("Skin Tag Removal", or STR) 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.
Read the detailed description
Common benign skin lesions include verruca, seborrheic, keratoses, fibromas, histiocytomas (dermatofibromas), nevi and skin tags (acrochordons). A skin tag is a small outgrowth of epidermal and dermal tissue and is common among middle-aged adults. Their size can range from one to several mm; usually flesh-colored and pedunculated. 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 vary.
Skin Tags can be removed by a dermatologist using excision, cauterization, or cryosurgical means. Most of these procedures are often done in a dermatology office and are an out-of-pocket cost. Recently there is a growing interest is 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.
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 STR 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 size. 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.
Under Protocol revision (version 2), the micro size band will be used on all skin tags measuring between 4-6 mm. The standard size will no longer be used and skin tags measuring between 2-4 mm will not be enrolled in the study.
The Investigator is planning to enroll up to 200 subjects, who will have the skin tags removed using the STR study devices. During the trial, each subject will complete a diary to document progress.
- Conditions
- Achrochordon
- Being tested
- STR Skin Tag Removal device with diary and follow-up
- Keywords
- Skin Tag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STR Skin Tag Removal device with diary and follow-upDevice
The Investigator will assign an STR version for use, stratifying the number of skin tags in each pool. The investigator will review the subject's skin tags and agree with the subject on the body location and skin tag that will be treated as well as whether the micro or standard size of the study device is appropriate. The Investigator will also verify that the skin tag does not present implications of cancerous tissue. After informed consent and reviewing device labeling, 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. 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). This diary is electronic (eDiary) and accessed through a secure website and must be fully completed to successfully finish the study.
| Study group | Role | What they receive |
|---|---|---|
| Skin Tag removal using the Manual Version of the STR | Experimental | Goal: successful removal of 60% of the skin tags treated with the manual version of 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). Receives: Device: STR Skin Tag Removal device with diary and follow-up |
| Skin Tag removal using the Auto Version of the STR | Experimental | Goal: successful removal of 60% of the skin tags treated with the auto version of 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). Receives: Device: STR Skin Tag Removal device with diary and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful removal of skin tag
Number of successful removals of treated acrochordons using the STR device
Measured: Treatment, 1-24 days; Safety follow-up on days 30-37
Secondary outcomes (1)
Comfort and Safety Issues
Amount and number of discomfort, issues or adverse events occurring during the study
Measured: Treatment, 1-24 days; Safety follow-up on days 30-37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start3 Jun 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion7 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchrochordonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UK Innovations GP LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Advarra
- Responsible party
- Sponsor
- Investigators
- Sunil S Dhawan, Principal investigator, Dermatology Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463613
- Sponsor's protocol ID
- Pro00078334
- Status last verified
- Nov 2025
- First submitted
- 31 May 2024
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Tag Removal Device; A Clinical Study to Determine Outcomes of Treating Adults With Acrochordons (Skin Tags)
- ClinicalTrials.gov ID
- NCT06463613
- Acronym / sponsor ID
- Pro00078334
- Conditions
- Achrochordon
- Keywords
- Skin Tag
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- UK Innovations GP LTDIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health, Advarra
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 7 Jan 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the use of a mechanical device to remove skin tags in adults.
The device ("Skin Tag Removal", or STR) 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.
Detailed description
Common benign skin lesions include verruca, seborrheic, keratoses, fibromas, histiocytomas (dermatofibromas), nevi and skin tags (acrochordons). A skin tag is a small outgrowth of epidermal and dermal tissue and is common among middle-aged adults. Their size can range from one to several mm; usually flesh-colored and pedunculated. 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 vary.
Skin Tags can be removed by a dermatologist using excision, cauterization, or cryosurgical means. Most of these procedures are often done in a dermatology office and are an out-of-pocket cost. Recently there is a growing interest is 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.
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 STR 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 size. 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.
Under Protocol revision (version 2), the micro size band will be used on all skin tags measuring between 4-6 mm. The standard size will no longer be used and skin tags measuring between 2-4 mm will not be enrolled in the study.
The Investigator is planning to enroll up to 200 subjects, who will have the skin tags removed using the STR study devices. During the trial, each subject will complete a diary to document progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Skin Tag removal using the Manual Version of the STR | Experimental | Device: STR Skin Tag Removal device with diary and follow-upGoal: successful removal of 60% of the skin tags treated with the manual version of 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). |
| Skin Tag removal using the Auto Version of the STR | Experimental | Device: STR Skin Tag Removal device with diary and follow-upGoal: successful removal of 60% of the skin tags treated with the auto version of 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). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults at least 22 years of age.
- Must be able to understand, speak, and read English sufficiently for completion of the trial.
- Subject has at least one skin tag meeting ALL of the following requirements:
- Subject has access to the internet via smartphone to complete the eDiary
Key exclusion criteria (11 listed)
- 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
- Any prior history of skin-related cancer
- Subject states that they are currently pregnant or intending to become pregnant during the course of the study
- Has an allergy to latex
- Current diagnosis of a bleeding disorder included but not limited to Hemophilia or Von Willebrand disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STR Skin Tag Removal device with diary and follow-upThe Investigator will assign an STR version for use, stratifying the number of skin tags in each pool. The investigator will review the subject's skin tags and agree with the subject on the body location and skin tag that will be treated as well as whether the micro or standard size of the study device is appropriate. The Investigator will also verify that the skin tag does not present implications of cancerous tissue. After informed consent and reviewing device labeling, 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. 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). This diary is electronic (eDiary) and accessed through a secure website and must be fully completed to successfully finish the study. | Device | Skin Tag removal using the Auto Version of the STR, Skin Tag removal using the Manual Version of the STR |
Primary outcome
Successful removal of skin tag
Time frame: Treatment, 1-24 days; Safety follow-up on days 30-37
Number of successful removals of treated acrochordons using the STR device
1 secondary outcome
Comfort and Safety Issues
Time frame: Treatment, 1-24 days; Safety follow-up on days 30-37
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil S Dhawan principal investigator
Dermatology Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STR Skin Tag Removal device with diary and follow-up in people with Achrochordon, run by UK Innovations GP LTD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful removal of skin tag (time frame: Treatment, 1-24 days; Safety follow-up on days 30-37). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.