ScarNCT01958450
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
A study testing Er:YAG laser and Bipolar radiofrequency with diode laser in people with Scar, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- Er:YAG laser and Bipolar radiofrequency with diode laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 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
Who cannot join
- taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
- anyone who received acne scar procedures within 6 months
- underlying diabetes mellitus, keloid, or 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: Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar
Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.
Read the detailed description
In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.
- Conditions
- Scar
- Being tested
- Er:YAG laser, Bipolar radiofrequency with diode laser
- Keywords
- acne scar, Laser therapy, wound healing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laserProcedure or surgery
acne scar treatment using Er:YAG laser
Bipolar radiofrequency with diode laserProcedure or surgery
acne scar treatment with bipolar radiofrequency combined with diode laser
| Study group | Role | What they receive |
|---|---|---|
| Er:YAG laser | Experimental | acne scar treatment using Er:YAG laser Receives: Procedure: Er:YAG laser |
| Bipolar radiofrequency with diode laser | Active comparator | Bipolar radiofrequency with diode laser Receives: Procedure: Bipolar radiofrequency with diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global asessment of acne scar
5 point grading of acne scar
Measured: 12 weeks
Secondary outcomes (2)
ECCA
quantative assessement of acne scar
Measured: 12 weeks
adverse effect assessment
adverse effect assessment
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 posted9 Oct 2013 (estimated)
- Study startJul 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 ScarStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hun Suh, Seoul National University Hospital
- 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
- NCT01958450
- Sponsor's protocol ID
- 2012-1061
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kutlubay Z, Gokdemir G. Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. J Cosmet Laser Ther. 2010 Apr;12(2):65-72. doi: 10.3109/14764171003706141.
PubMed 20331342
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar
- ClinicalTrials.gov ID
- NCT01958450
- Acronym / sponsor ID
- 2012-1061
- Conditions
- Scar
- Keywords
- acne scar, Laser therapy, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 9 Oct 2013 (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 of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.
Detailed description
In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Er:YAG laser | Experimental | Procedure: Er:YAG laseracne scar treatment using Er:YAG laser |
| Bipolar radiofrequency with diode laser | Active comparator | Procedure: Bipolar radiofrequency with diode laserBipolar radiofrequency with diode laser |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- moderate acne scar
Key exclusion criteria (3 listed)
- taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin
- anyone who received acne scar procedures within 6 months
- underlying diabetes mellitus, keloid, or 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 |
|---|---|---|
| Er:YAG laseracne scar treatment using Er:YAG laser | Procedure or surgery | Er:YAG laser |
| Bipolar radiofrequency with diode laseracne scar treatment with bipolar radiofrequency combined with diode laser | Procedure or surgery | Bipolar radiofrequency with diode laser |
Primary outcome
Global asessment of acne scar
Time frame: 12 weeks
5 point grading of acne scar
2 secondary outcomes
ECCA
Time frame: 12 weeks
adverse effect assessment
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 11 Oct 2013.
- Background: PubMed 20331342Kutlubay Z, Gokdemir G. Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. J Cosmet Laser Ther. 2010 Apr;12(2):65-72. doi: 10.3109/14764171003706141.
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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 Er:YAG laser and Bipolar radiofrequency with diode laser in people with 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 1 inclusion and 3 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 11 Oct 2013. 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 asessment 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 NCT01958450, 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 11 Oct 2013.