NCT02207738

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
Last Updated

August 4, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

June 26, 2014

Last Update Submit

July 31, 2014

Conditions

Keywords

acneacne scarmicroneedling radiofrequencybipolar radiofrequency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • ECCA

    12 weeks

  • Adverse effect

    12 weeks

Study Arms (2)

microneedling radiofrequency device

EXPERIMENTAL

microneedling radiofrequency

Device: microneedling radiofrequency device

bipolar radiofrequency device

ACTIVE COMPARATOR

bipolar radiofrequency treatment

Device: bipolar radiofrequency

Interventions

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.

Also known as: INFINI(Lutronics, Goyang, Korea)
microneedling radiofrequency device

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.

Also known as: Polaris(syneron, israel)
bipolar radiofrequency device

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • moderate acne scar
  • mild to moderate acne lesions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related 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.

    PMID: 22899398BACKGROUND

MeSH Terms

Conditions

Acne VulgarisCicatrix

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dae Hun Suh, PhD

    Department of Dermatology, Seoul National University College of Medicine

    STUDY CHAIR
  • Seonguk Min, Msc

    Department of Dermatology, Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2014

First Posted

August 4, 2014

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 4, 2014

Record last verified: 2014-07

Locations