Electrodermabrasion Compared to Dermabrasion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Eisen, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01769989
First received: January 15, 2013
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Scar
Procedure: Electrodermabrasion
Procedure: Dermabrasion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of the Safety and Efficacy of Electrodermabrasion in Improving the Appearance of Scars That Result From Dermatologic Surgery Compared to Treatment With Dermabrasion

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Electrodermabrasion compared to dermabrasion [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    To determine if electrodermabrasion improves the cosmetic appearance of scars that result from dermatologic surgery better than the current method of dermabrasion.


Estimated Enrollment: 33
Study Start Date: February 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Eletrodermabrasion
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
Active Comparator: Dermabrasion
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769989

Locations
United States, California
UC Davis, Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Daniel Eisen, M.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Daniel Eisen, MD, Associate Professor of Clinical Dermatology, University of California, Davis
ClinicalTrials.gov Identifier: NCT01769989     History of Changes
Other Study ID Numbers: 259842
Study First Received: January 15, 2013
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014