NCT03259295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

August 21, 2017

Results QC Date

December 6, 2021

Last Update Submit

February 13, 2023

Conditions

Achrochordon

Keywords

skin tag

Outcome Measures

Primary Outcomes (1)

  • Re-occurrence Rate of Skin Tags

    Percentage of subjects who experience a re-occurrence of the skin tag at the removal site.

    3 months

Secondary Outcomes (7)

  • Percentage of Permanent Scars Among Lesion Sites

    3 months

  • Percentage of Scar Tissue Formation Among Lesion Sites

    3 months

  • Percentage of Discoloration Among Subjects

    3 months

  • Percentage of Pain/Numbness Where Skin Tag Was Removed

    3 months

  • Satisfaction With Pain Post Procedure

    2 months post procedure

  • +2 more secondary outcomes

Study Arms (1)

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.

Device: Digiclamp (Skin tag removal initial plus follow-up)

Interventions

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.

Skin tag removal initial visit plus follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Office of Raymond Marquette, MD

Ocala, Florida, 34471, United States

Location

Related Publications (4)

  • 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.

    PMID: 9010187BACKGROUND

  • Schmook 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.

    PMID: 14522635BACKGROUND

  • Kahana 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.

    PMID: 2438887BACKGROUND

  • Banik R, Lubach D. Skin tags: localization and frequencies according to sex and age. Dermatologica. 1987;174(4):180-3. doi: 10.1159/000249169.

    PMID: 3582706BACKGROUND

Results Point of Contact

Title
Juan Carlos Roig
Organization
University of Florida
roigjc@peds.ufl.edu
352-273-8985

Study Officials

  • Juan C Roig, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 23, 2017

Study Start

December 1, 2017

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

February 15, 2023

Results First Posted

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)