Trial Outcomes & Findings for Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp (NCT NCT03259295)
NCT ID: NCT03259295
Last Updated: 2023-02-15
Results Overview
Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 months
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Skin Tag Removal Initial Visit 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.
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.
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp
Baseline characteristics by cohort
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Age, Continuous
|
45.8 years
STANDARD_DEVIATION 9.96 • n=99 Participants
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|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Weight
|
182 pounds
STANDARD_DEVIATION 43.9 • n=99 Participants
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Height
|
66.4 inches
STANDARD_DEVIATION 3.07 • n=99 Participants
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Number of lesions
|
2.5 lesions
STANDARD_DEVIATION 1.15 • n=99 Participants
|
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Location of lesions
neck
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19 lesions
n=99 Participants
|
|
Location of lesions
maxilla
|
1 lesions
n=99 Participants
|
|
Location of lesions
axilla
|
7 lesions
n=99 Participants
|
|
Location of lesions
back
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8 lesions
n=99 Participants
|
|
Location of lesions
areola
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1 lesions
n=99 Participants
|
|
Location of lesions
thigh
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2 lesions
n=99 Participants
|
|
Location of lesions
rib cage
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1 lesions
n=99 Participants
|
|
Location of lesions
buttock
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1 lesions
n=99 Participants
|
|
Location of lesions
mandible
|
2 lesions
n=99 Participants
|
|
Location of lesions
shoulder
|
2 lesions
n=99 Participants
|
|
Location of lesions
abdomen
|
2 lesions
n=99 Participants
|
|
Location of lesions
chest
|
4 lesions
n=99 Participants
|
|
width of lesion
|
0.404 cm
STANDARD_DEVIATION 0.276 • n=99 Participants
|
|
height of lesion
|
0.376 cm
STANDARD_DEVIATION 0.252 • n=99 Participants
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PRIMARY outcome
Timeframe: 3 monthsPercentage of subjects who experience a re-occurrence of the skin tag at the removal site.
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Re-occurrence Rate of Skin Tags
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0 Participants
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SECONDARY outcome
Timeframe: 3 monthsPercentage of subjects who develop a scar at the removal site
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Percentage of Permanent Scars Among Lesion Sites
|
1 Participants
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SECONDARY outcome
Timeframe: 3 monthsPercentage of subjects who develop scar tissue or keloid at the site of removal
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Percentage of Scar Tissue Formation Among Lesion Sites
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0 Participants
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SECONDARY outcome
Timeframe: 3 monthsPercentage of subjects who develop discoloration at the site of removal
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Percentage of Discoloration Among Subjects
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3 Participants
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SECONDARY outcome
Timeframe: 3 monthsPercentage of subjects who develop pain/numbness at the site of removal
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Percentage of Pain/Numbness Where Skin Tag Was Removed
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0 Participants
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SECONDARY outcome
Timeframe: 2 months post procedureAll study participants were asked three questions in a post procedure satisfaction survey. 1\. How satisfied are you with the amount of pain you experienced while having your skin tag removed? Study participants responded whether they were "very satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied", "somewhat dissatisfied", "very dissatisfied". Subjects were counted in each category and reported.
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Satisfaction With Pain Post Procedure
Very satisfied
|
20 Participants
|
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Satisfaction With Pain Post Procedure
Somewhat satisfied
|
0 Participants
|
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Satisfaction With Pain Post Procedure
Very dissatisfied
|
0 Participants
|
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Satisfaction With Pain Post Procedure
Neither satisfied nor dissatisfied
|
0 Participants
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Satisfaction With Pain Post Procedure
Somewhat dissatisfied
|
0 Participants
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SECONDARY outcome
Timeframe: 2 months post procedureAll 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.
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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Satisfaction With What the Area Looked Like Post Procedure
Very satisfied with how the area looked like where the skin tag used to be
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19 Participants
|
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Satisfaction With What the Area Looked Like Post Procedure
Somewhat satisfied with what the area looked like
|
1 Participants
|
|
Satisfaction With What the Area Looked Like Post Procedure
Neither satisfied nor dissatisfied
|
0 Participants
|
|
Satisfaction With What the Area Looked Like Post Procedure
Somewhat dissatisfied
|
0 Participants
|
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Satisfaction With What the Area Looked Like Post Procedure
Very dissatisfied
|
0 Participants
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SECONDARY outcome
Timeframe: 2 months post procedureAll 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.
Outcome measures
| Measure |
Skin Tag Removal Initial Visit Plus Follow-up
n=20 Participants
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.
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.
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|---|---|
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How Likely to Recommend the Procedure to Friends and Family
Very likely to recommend the procedure to friends and family
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20 Participants
|
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How Likely to Recommend the Procedure to Friends and Family
Somewhat likely
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0 Participants
|
|
How Likely to Recommend the Procedure to Friends and Family
Very unlikely
|
0 Participants
|
|
How Likely to Recommend the Procedure to Friends and Family
Neither likely nor unlikely
|
0 Participants
|
|
How Likely to Recommend the Procedure to Friends and Family
Somewhat unlikely
|
0 Participants
|
Adverse Events
Skin Tag Removal Initial Visit Plus Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place