Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
Primary Purpose
Scar
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Er:YAG laser
Bipolar radiofrequency with diode laser
Sponsored by
About this trial
This is an interventional treatment trial for Scar focused on measuring acne scar, Laser therapy, wound healing
Eligibility Criteria
Inclusion Criteria:
- moderate acne scar
Exclusion Criteria:
- taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
- anyone who received acne scar procedures within 6 months
- underlying diabetes mellitus, keloid, or malignancy
Sites / Locations
- Department of Dermatology, Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Er:YAG laser
Bipolar radiofrequency with diode laser
Arm Description
acne scar treatment using Er:YAG laser
Bipolar radiofrequency with diode laser
Outcomes
Primary Outcome Measures
Global asessment of acne scar
5 point grading of acne scar
Secondary Outcome Measures
ECCA
quantative assessement of acne scar
adverse effect assessment
adverse effect assessment
Full Information
NCT ID
NCT01958450
First Posted
October 6, 2013
Last Updated
October 9, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01958450
Brief Title
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
Official Title
Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.
Detailed Description
In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
acne scar, Laser therapy, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Er:YAG laser
Arm Type
Experimental
Arm Description
acne scar treatment using Er:YAG laser
Arm Title
Bipolar radiofrequency with diode laser
Arm Type
Active Comparator
Arm Description
Bipolar radiofrequency with diode laser
Intervention Type
Procedure
Intervention Name(s)
Er:YAG laser
Intervention Description
acne scar treatment using Er:YAG laser
Intervention Type
Procedure
Intervention Name(s)
Bipolar radiofrequency with diode laser
Intervention Description
acne scar treatment with bipolar radiofrequency combined with diode laser
Primary Outcome Measure Information:
Title
Global asessment of acne scar
Description
5 point grading of acne scar
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ECCA
Description
quantative assessement of acne scar
Time Frame
12 weeks
Title
adverse effect assessment
Description
adverse effect assessment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
moderate acne scar
Exclusion Criteria:
taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
anyone who received acne scar procedures within 6 months
underlying diabetes mellitus, keloid, or malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hun Suh, PhD
Organizational Affiliation
Department of Dermatology, Seoul National University College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seonguk Min, Msc
Organizational Affiliation
Department of Dermatology, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20331342
Citation
Kutlubay Z, Gokdemir G. Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. J Cosmet Laser Ther. 2010 Apr;12(2):65-72. doi: 10.3109/14764171003706141.
Results Reference
background
Learn more about this trial
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
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