Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 82 for:    acne AND Acne Scars

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02207738
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Acne Scar Device: microneedling radiofrequency device Device: bipolar radiofrequency Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar
Study Start Date : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: microneedling radiofrequency device
microneedling radiofrequency
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.
Other Name: INFINI(Lutronics, Goyang, Korea)

Active Comparator: bipolar radiofrequency device
bipolar radiofrequency treatment
Device: 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.
Other Name: Polaris(syneron, israel)




Primary Outcome Measures :
  1. Global assessment of acne scar [ Time Frame: 12 weeks ]
    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 :
  1. ECCA [ Time Frame: 12 weeks ]
    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

  2. Adverse effect [ Time Frame: 12 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207738


Locations
Layout table for location information
Korea, Republic of
Department of Dermatology, Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Dae Hun Suh, PhD Department of Dermatology, Seoul National University College of Medicine
Principal Investigator: Seonguk Min, Msc Department of Dermatology, Seoul National University College of Medicine

Publications:
Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02207738     History of Changes
Other Study ID Numbers: 2012-1062
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: July 2014

Keywords provided by Seoul National University Hospital:
acne
acne scar
microneedling radiofrequency
bipolar radiofrequency