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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
Sponsor:
Collaborator:
XDG Technologies, LLC
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Achrochordon Device: Digiclamp (Skin tag removal initial) Device: Digiclamp (Skin tag removal follow-up) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of permanent scars among subjects [ Time Frame: 3 months ]
    Proportion of subjects who develop a scar at the removal site

  2. 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

  3. Rate of discoloration among subjects [ Time Frame: 3 months ]
    Proportion of subjects who develop discoloration at the site of removal

  4. Rate of hyposensitivity where skin tag was removed [ Time Frame: 3 months ]
    Proportion of subjects who develop hyposensitivity at the site of removal

  5. Rate of hypersensitivity where skin tag was removed [ Time Frame: 3 months ]
    Proportion of subjects who develop hypersensitivity at the site of removal



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with simple skin tag(s) measuring up to 1 centimeter width at the base of the skin tag

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
Office of Raymond Marquette, MD
Ocala, Florida, United States, 34471
Sponsors and Collaborators
University of Florida
XDG Technologies, LLC
Investigators
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Principal Investigator: Juan C Roig, MD University of Florida

Publications:
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03259295     History of Changes
Other Study ID Numbers: 20171314 - WIRB
PRO00002692 ( Other Identifier: University of Florida Project # )
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Florida:
skin tag