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Electrodermabrasion Compared to Dermabrasion

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Eisen, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01769989
First received: January 15, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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:

MedlinePlus related topics: Scars
U.S. FDA Resources

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
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 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
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: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013