AcneNCT02207738
Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar
A study testing microneedling radiofrequency device and bipolar radiofrequency in people with Acne and Scar, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- What is being tested?
- microneedling radiofrequency device and bipolar radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- moderate acne scar
- mild to moderate acne lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Seoul National University College of Medicine
Seoul, 110-744
About this study
Official title: Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar
Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar.
Read the 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
- Being tested
- microneedling radiofrequency device, bipolar radiofrequency
- Keywords
- acne, acne scar, microneedling radiofrequency, bipolar radiofrequency
- Medical subject headings
- Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling radiofrequency deviceDevice
Also called INFINI(Lutronics, Goyang, Korea)
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 radiofrequencyDevice
Also called Polaris(syneron, israel)
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.
| Study group | Role | What they receive |
|---|---|---|
| microneedling radiofrequency device | Experimental | microneedling radiofrequency Receives: Device: microneedling radiofrequency device |
| bipolar radiofrequency device | Active comparator | bipolar radiofrequency treatment Receives: Device: bipolar radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (2)
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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dae Hun Suh, PhD, Study chair, Department of Dermatology, Seoul National University College of MedicineSeonguk Min, Msc, Principal investigator, Department of Dermatology, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207738
- Sponsor's protocol ID
- 2012-1062
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22899398
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar
- ClinicalTrials.gov ID
- NCT02207738
- Acronym / sponsor ID
- 2012-1062
- Keywords
- acne, acne scar, microneedling radiofrequency, bipolar radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microneedling radiofrequency device | Experimental | Device: microneedling radiofrequency devicemicroneedling radiofrequency |
| bipolar radiofrequency device | Active comparator | Device: bipolar radiofrequencybipolar radiofrequency treatment |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- moderate acne scar
- mild to moderate acne lesions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microneedling radiofrequency deviceAlso: INFINI(Lutronics, Goyang, Korea)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. | Device | microneedling radiofrequency device |
| bipolar radiofrequencyAlso: Polaris(syneron, israel)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. | Device | bipolar radiofrequency device |
Primary outcome
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
2 secondary outcomes
ECCA
Time frame: 12 weeks
Adverse effect
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
- Background: PubMed 22899398Yeung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Hun Suh, PhD study chair
Department of Dermatology, Seoul National University College of Medicine
Seonguk Min, Msc principal investigator
Department of Dermatology, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling radiofrequency device and bipolar radiofrequency in people with Acne and Scar, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global assessment of acne scar (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014.