Back to resultsComparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar
Primary Purpose
Acne, Scar
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
microneedling radiofrequency device
bipolar radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring acne, acne scar, microneedling radiofrequency, bipolar radiofrequency
Eligibility Criteria
Inclusion Criteria:
- moderate acne scar
- mild to moderate acne lesions
Exclusion Criteria:
- taking acne medication oral drugs within 2 months topical drugs within 2 weeks
- taken anu procedures for acne scar within 6 months
- taking steroid,nonsteroidal antiinflammtory drugs, isotretinoin
- underlying diabetes mellitus, keloid, or any 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
microneedling radiofrequency device
bipolar radiofrequency device
Arm Description
microneedling radiofrequency
bipolar radiofrequency treatment
Outcomes
Primary Outcome Measures
Global assessment of acne scar
5-point grading of acne scar quartile assessment of acne scar improvement through comparing the photos taken before treatment and after treatment
Secondary Outcome Measures
ECCA
quantitative assessment of acne scar ECCA assessment is established by previous article. this method quantifies severity of acne scar by counting the number of acne scar categorized by their shape. Then, the number of scars are multiplied by weighing factors determined by scar types. ECCA is the total sum of these points. please refer the Dreno et al, Dermatology, 2007;214:46-51
Adverse effect
adverse effects were measured by Epithelization Scale. ES is the total sum of evaluation of three components after wounding. please refer this article Min et al, Wound Repair and Regen, 2014;22(2):212-9
Full Information
NCT ID
NCT02207738
First Posted
June 26, 2014
Last Updated
July 31, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02207738
Brief Title
Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar
Official Title
Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar.
Detailed Description
Efficacy and safety of microneedling radiofrequency for acne scar Efficacy and safety bipolar radiofrequency treatment for acne scar compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Scar
Keywords
acne, acne scar, microneedling radiofrequency, bipolar radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
microneedling radiofrequency device
Arm Type
Experimental
Arm Description
microneedling radiofrequency
Arm Title
bipolar radiofrequency device
Arm Type
Active Comparator
Arm Description
bipolar radiofrequency treatment
Intervention Type
Device
Intervention Name(s)
microneedling radiofrequency device
Other Intervention Name(s)
INFINI(Lutronics, Goyang, Korea)
Intervention Description
Microneedling radiofrequency device is composed of 49 insulated microneedle which emit radiofrequency from the needle tip. This radiofreqeuncy generates dermal heat which evokes biological effect.
Intervention Type
Device
Intervention Name(s)
bipolar radiofrequency
Other Intervention Name(s)
Polaris(syneron, israel)
Intervention Description
bipolar radiofrequency instrument gives out bipolar radiofrequency from the hand piece tip. This bipolar radiofrequency generates dermal heat which has a lot of bilogical effect.
Primary Outcome Measure Information:
Title
Global assessment of acne scar
Description
5-point grading of acne scar quartile assessment of acne scar improvement through comparing the photos taken before treatment and after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ECCA
Description
quantitative assessment of acne scar ECCA assessment is established by previous article. this method quantifies severity of acne scar by counting the number of acne scar categorized by their shape. Then, the number of scars are multiplied by weighing factors determined by scar types. ECCA is the total sum of these points. please refer the Dreno et al, Dermatology, 2007;214:46-51
Time Frame
12 weeks
Title
Adverse effect
Description
adverse effects were measured by Epithelization Scale. ES is the total sum of evaluation of three components after wounding. please refer this article Min et al, Wound Repair and Regen, 2014;22(2):212-9
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
mild to moderate acne lesions
Exclusion Criteria:
taking acne medication oral drugs within 2 months topical drugs within 2 weeks
taken anu procedures for acne scar within 6 months
taking steroid,nonsteroidal antiinflammtory drugs, isotretinoin
underlying diabetes mellitus, keloid, or any 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
22899398
Citation
Yeung CK, Chan NP, Shek SY, Chan HH. Evaluation of combined fractional radiofrequency and fractional laser treatment for acne scars in Asians. Lasers Surg Med. 2012 Oct;44(8):622-30. doi: 10.1002/lsm.22063. Epub 2012 Aug 16.
Results Reference
background
Learn more about this trial
Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar
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