Acne ScarNCT02396290
Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar
A study testing fractional carbon dioxide laser with platelet rich plasma and fractional carbon dioxide laser with NS in people with Acne Scar, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scar
- What is being tested?
- fractional carbon dioxide laser with platelet rich plasma and fractional carbon dioxide laser with NS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Sep 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 to severe acne scar
Who cannot join
- taken procedures for acne scar 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: Clinical Study on Efficacy and Safety of Platelet Rich Plasma Combined With Laser for Scar Treatment
Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar
Read the detailed description
Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.
- Conditions
- Acne Scar
- Being tested
- fractional carbon dioxide laser with platelet rich plasma, fractional carbon dioxide laser with NS
- Keywords
- acne scar, fractional carbon dioxide laser, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional carbon dioxide laser with platelet rich plasmaProcedure or surgery
Also called COFRAX with autologous PRP
fractional carbon dioxide laser followed by platelet rich plasma injection
fractional carbon dioxide laser with NSProcedure or surgery
Also called COFRAX with normal saline
fractional carbon dioxide laser followed by normal saline injection
| Study group | Role | What they receive |
|---|---|---|
| fractional CO2 laser with PRP | Experimental | fractional carbon dioxide laser followed by intradermal injection of platelet rich plasma Receives: Procedure: fractional carbon dioxide laser with platelet rich plasma |
| fractional CO2 laser with NS | Active comparator | fractional carbon dioxide laser followed by intradermal injection of NS Receives: Procedure: fractional carbon dioxide laser with NS |
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
Measured: 12 weeks
Secondary outcomes (2)
ECCA (échelle d'évaluation clinique des cicatrices d'acné)
quantitative analysis of acne scar
Measured: 12 weeks
adverse effect assessment
adverse effect assessment - erythema index, Epithelization Scale (0-12 point)
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 posted24 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 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 Acne 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
- 29 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
- NCT02396290
- Sponsor's protocol ID
- 2012-0998
- Status last verified
- Jul 2013
- First submitted
- 9 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tierney EP, Eisen RF, Hanke CW. Fractionated CO2 laser skin rejuvenation. Dermatol Ther. 2011 Jan-Feb;24(1):41-53. doi: 10.1111/j.1529-8019.2010.01377.x.
PubMed 21276157
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Efficacy and Safety of Platelet Rich Plasma Combined With Laser for Scar Treatment
- ClinicalTrials.gov ID
- NCT02396290
- Acronym / sponsor ID
- 2012-0998
- Conditions
- Acne Scar
- Keywords
- acne scar, fractional carbon dioxide laser, platelet rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Mar 2015 (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.
Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar
Detailed description
Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractional CO2 laser with PRP | Experimental | Procedure: fractional carbon dioxide laser with platelet rich plasmafractional carbon dioxide laser followed by intradermal injection of platelet rich plasma |
| fractional CO2 laser with NS | Active comparator | Procedure: fractional carbon dioxide laser with NSfractional carbon dioxide laser followed by intradermal injection of NS |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- moderate to severe acne scar
Key exclusion criteria (2 listed)
- taken procedures for acne scar 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 |
|---|---|---|
| fractional carbon dioxide laser with platelet rich plasmaAlso: COFRAX with autologous PRPfractional carbon dioxide laser followed by platelet rich plasma injection | Procedure or surgery | fractional CO2 laser with PRP |
| fractional carbon dioxide laser with NSAlso: COFRAX with normal salinefractional carbon dioxide laser followed by normal saline injection | Procedure or surgery | fractional CO2 laser with NS |
Primary outcome
Global assessment of acne scar
Time frame: 12 weeks
5-point grading of acne scar
2 secondary outcomes
ECCA (échelle d'évaluation clinique des cicatrices d'acné)
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 24 Mar 2015.
- Background: PubMed 21276157Tierney EP, Eisen RF, Hanke CW. Fractionated CO2 laser skin rejuvenation. Dermatol Ther. 2011 Jan-Feb;24(1):41-53. doi: 10.1111/j.1529-8019.2010.01377.x.
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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 fractional carbon dioxide laser with platelet rich plasma and fractional carbon dioxide laser with NS in people with Acne 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 2 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 24 Mar 2015. 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 NCT02396290, 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 24 Mar 2015.