NCT01769989

Brief Summary

The purpose of this study is to determine if electrodermabrasion improves the cosmetic appearance of raise or bumpy scars or scars that are a different color or texture than the surrounding skin resulting from dermatologic surgery and whether it is as good as to the already used method of dermabrasion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

February 1, 2009

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

January 15, 2013

Last Update Submit

May 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Electrodermabrasion compared to dermabrasion

    To determine if electrodermabrasion improves the cosmetic appearance of scars that result from dermatologic surgery better than the current method of dermabrasion.

    3 months

Study Arms (2)

Eletrodermabrasion

ACTIVE COMPARATOR

The side treated with electrodermabrasion will be burned with an electric cautery machine to remove the outermost layer of skin as well as the lumps and bumps and a small area of surrounding skin.

Procedure: Electrodermabrasion

Dermabrasion

ACTIVE COMPARATOR

The side treated with dermabrasion will be scraped with a sterile piece of sandpaper until the outermost layer of skin and lumps and bumps have been removed and a small layer of surround skin.

Procedure: Dermabrasion

Interventions

Eletrodermabrasion
DermabrasionPROCEDURE
Dermabrasion

Eligibility Criteria

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

You may qualify if:

  • Not incarcerated
  • No mental impairments that could potentially interfere with the subject's ability to understand the various scar revision modalities and their potential risks and benefits, and thereby ability to provide informed consent
  • No bleeding disorders
  • A patient at UC Davis Medical Center's Department of Dermatology who has undergone a dermatologic surgery procedure and is not satisfied with the appearance of his/her scar

You may not qualify if:

  • Incarcerated
  • With mental impairment(s) that could potentially interfere with subject's ability to understand the various scare revision modalities and their potential risks and benefits, and thereby ability to provide informed consent
  • With a bleeding disorder
  • With any other contraindication to the treatment used in the study
  • Not a patient at UC Davis Medical Center's Department of Dermatology
  • Subjects who are not willing or able to return for follow-up assessments
  • Subjects who are not able to give informed consent to enter the study
  • Subjects who are not willing to complete the visual analog scale following treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Cicatrix

Interventions

Dermabrasion

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Daniel Eisen, M.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

February 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations