- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769989
Electrodermabrasion Compared to Dermabrasion
May 24, 2017 updated by: University of California, Davis
Evaluation of the Safety and Efficacy of Electrodermabrasion in Improving the Appearance of Scars That Result From Dermatologic Surgery Compared to Treatment With Dermabrasion
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- UC Davis, Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 15, 2013
First Submitted That Met QC Criteria
January 15, 2013
First Posted (Estimate)
January 17, 2013
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 259842
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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