Study to Evaluate the Efficacy of Removing Skin Tags With Digiclamp
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|ClinicalTrials.gov Identifier: NCT03259295|
Recruitment Status : Enrolling by invitation
First Posted : August 23, 2017
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Achrochordon||Device: Digiclamp (Skin tag removal initial) Device: Digiclamp (Skin tag removal follow-up)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Research on Current Prototypes of the Digiclamp. Short Term and Long Term Outcomes of Treating Adults With Achrocordons (Skin Tags)|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Skin tag removal initial
Removal of skin tags 1 cm or less using Digiclamp
Device: Digiclamp (Skin tag removal initial)
Skin tag will be assessed for size, location, and overall appearance. After assessment 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.
Experimental: Skin tag removal follow-up
Follow-up 2-3 months after skin tag removal.
Device: Digiclamp (Skin tag removal follow-up)
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.
- Re-occurrence rate of skin tags [ Time Frame: 3 months ]Proportion of subjects who experience a re-occurrence of the skin tag at the removal site.
- Rate of permanent scars among subjects [ Time Frame: 3 months ]Proportion of subjects who develop a scar at the removal site
- Rate of scar tissue formation among subjects [ Time Frame: 3 months ]Proportion of subjects who develop scar tissue or keloid at the site of removal
- Rate of discoloration among subjects [ Time Frame: 3 months ]Proportion of subjects who develop discoloration at the site of removal
- Rate of hyposensitivity where skin tag was removed [ Time Frame: 3 months ]Proportion of subjects who develop hyposensitivity at the site of removal
- Rate of hypersensitivity where skin tag was removed [ Time Frame: 3 months ]Proportion of subjects who develop hypersensitivity at the site of removal
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259295
|United States, Florida|
|Office of Raymond Marquette, MD|
|Ocala, Florida, United States, 34471|
|Principal Investigator:||Juan C Roig, MD||University of Florida|