Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar

Study Overview
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Brief Summary
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Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar.

Detailed Description
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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

Official Title
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Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar

Conditions
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Acne, Scar

Intervention / Treatment
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* Device: microneedling radiofrequency device
* Device: bipolar radiofrequency


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microneedling radiofrequency device<br>microneedling radiofrequency | Device: microneedling radiofrequency device<br>* 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.<br>* Other names: INFINI(Lutronics, Goyang, Korea);|
| Active Comparator: bipolar radiofrequency device<br>bipolar radiofrequency treatment | Device: bipolar radiofrequency<br>* 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.<br>* Other names: Polaris(syneron, israel);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, acne scar, microneedling radiofrequency, bipolar radiofrequency