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Electrodermabrasion Compared to Dermabrasion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769989
First Posted: January 17, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    To determine if electrodermabrasion improves the cosmetic appearance of scars that result from dermatologic surgery better than the current method of dermabrasion.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01769989     History of Changes
Other Study ID Numbers: 259842
First Submitted: January 15, 2013
First Posted: January 17, 2013
Last Update Posted: May 30, 2017
Last Verified: May 2017