AchrochordonNCT03259295
Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp
A study testing Digiclamp (Skin tag removal initial plus follow-up) in people with Achrochordon, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Achrochordon
- What is being tested?
- Digiclamp (Skin tag removal initial plus follow-up)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Office of Raymond Marquette, MD
Ocala, Florida, 34471
About this study
Official title: Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)
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.
Read the 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.
- Conditions
- Achrochordon
- Being tested
- Digiclamp (Skin tag removal initial plus follow-up)
- Keywords
- skin tag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digiclamp (Skin tag removal initial plus follow-up)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin tag removal initial visit plus follow-up | Experimental | Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. Receives: Device: Digiclamp (Skin tag removal initial plus follow-up) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-occurrence Rate of Skin Tags
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
Measured: 3 months
Secondary outcomes (7)
Percentage of Permanent Scars Among Lesion Sites
Percentage of subjects who develop a scar at the removal site
Measured: 3 months
Percentage of Scar Tissue Formation Among Lesion Sites
Percentage of subjects who develop scar tissue or keloid at the site of removal
Measured: 3 months
Percentage of Discoloration Among Subjects
Percentage of subjects who develop discoloration at the site of removal
Measured: 3 months
Percentage of Pain/Numbness Where Skin Tag Was Removed
Percentage of subjects who develop pain/numbness at the site of removal
Measured: 3 months
Satisfaction With Pain Post Procedure
All study participants were asked three questions in a post procedure satisfaction survey.
- 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.
Measured: 2 months post procedure
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.
Measured: 2 months post procedure
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.
Measured: 2 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Dec 2017
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AchrochordonStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- XDG Technologies, LLC
- Responsible party
- Sponsor
- Investigators
- Juan C Roig, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259295
- Sponsor's protocol ID
- 20171314 - WIRB
- Other IDs
- PRO00002692
- Status last verified
- Feb 2023
- First submitted
- 21 Aug 2017
- Last updated
- 15 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 9010187Schmook 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.
PubMed 14522635Kahana 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.
PubMed 2438887Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.
PubMed 3582706
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)
- ClinicalTrials.gov ID
- NCT03259295
- Acronym / sponsor ID
- 20171314 - WIRB
- Conditions
- Achrochordon
- Keywords
- skin tag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- XDG Technologies, LLC
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 15 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin tag removal initial visit plus follow-up | Experimental | Device: Digiclamp (Skin tag removal initial plus follow-up)Removal of skin tags 1 cm or less using Digiclamp and follow-up 2-3 months after skin tag removal to assess functionality and effectiveness of the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| 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. | Device | Skin tag removal initial visit plus follow-up |
Primary outcome
Re-occurrence Rate of Skin Tags
Time frame: 3 months
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
7 secondary outcomes
Percentage of Permanent Scars Among Lesion Sites
Time frame: 3 months
Percentage of Scar Tissue Formation Among Lesion Sites
Time frame: 3 months
Percentage of Discoloration Among Subjects
Time frame: 3 months
Percentage of Pain/Numbness Where Skin Tag Was Removed
Time frame: 3 months
Satisfaction With Pain Post Procedure
Time frame: 2 months post procedure
Satisfaction With What the Area Looked Like Post Procedure
Time frame: 2 months post procedure
How Likely to Recommend the Procedure to Friends and Family
Time frame: 2 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9010187Watson 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.
- Background: PubMed 14522635Schmook 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.
- Background: PubMed 2438887Kahana 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.
- Background: PubMed 3582706Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.
- 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.
Juan C Roig, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digiclamp (Skin tag removal initial plus follow-up) in people with Achrochordon, run by University of Florida 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 15 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Re-occurrence Rate of Skin Tags (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259295, which also lists 4 linked publications.
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 15 Feb 2023.