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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207738
• Other study ID #: 2012-1062
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: July 31, 2014
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne
• Scar

Intervention

Device:
• microneedling radiofrequency device
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.
• bipolar radiofrequency
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Dermatology, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes