ScarNCT02472405
Multiplex Laser vs. PDL (Pulsed Dye Laser ) in the Treatment of Surgical Scars
A study testing 595/1064nm Multiplex Laser and 595nm PDL in people with Scar, run by University of Miami at 1 site in United States.
Trial summary
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Scar
- What is being tested?
- 595/1064nm Multiplex Laser and 595nm PDL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick skin types 1-3
- Suture line should be at least 3 cm long
Who cannot join
- The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study
- Pregnant or lactating females
- Fitzpatrick skin type 4-6
- A history of keloids or hypertrophic scars
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Comparing the 595/1064nm Multiplex Laser to the 595nm PDL in the Treatment of Surgical Scars in a Blinded, Randomized, Controlled Trial
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
Read the detailed description
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
Patients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.
The surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.
- Conditions
- Scar
- Being tested
- 595/1064nm Multiplex Laser, 595nm PDL
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
595/1064nm Multiplex LaserDevice
The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.
595nm PDLDevice
One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
| Study group | Role | What they receive |
|---|---|---|
| 595nm PDL | Active comparator | One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. Receives: Device: 595nm PDL |
| 595/1064nm Multiplex Laser | Active comparator | One third of the scar will be treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. Receives: Device: 595/1064nm Multiplex Laser |
| Control | No intervention | One third of the scar will be left untreated for the duration of the study. A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSAS (The Patient and Observer Scar Assessment Scale) Measure
POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Crossover
- Model description
- Each participant scar was randomized to the 3 treatment arms.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyvan Nouri, University of Miami
- Investigators
- Keyvan Nouri, MD, Principal investigator, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472405
- Sponsor's protocol ID
- 20140348
- Status last verified
- Jul 2018
- First submitted
- 2 Mar 2015
- Last updated
- 21 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the 595/1064nm Multiplex Laser to the 595nm PDL in the Treatment of Surgical Scars in a Blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02472405
- Acronym / sponsor ID
- 20140348
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
Detailed description
This study aims to determine if the 595nm Pulsed dye laser, the combined 595/1064nm Multiplex laser or no treatment results in a better outcome in the quality of the surgical scar using the multiplex cynergy laser, starting treatment the day of suture removal.
Patients will be offered the opportunity of enrolling in the trial before their surgery. If they qualify and agree to participate they will sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) form.
The surgical defect should be closed primarily, with the minimal scar length being 3cm. The scar will be randomized into 3 equal thirds, each third will randomly receive either: no treatment, 595nm PDL, or 595/1064nm Multiplex laser. A total of 3 laser treatments will be performed over a period of 3 weeks (one treatment session performed every week), and the patient will come in for a final follow up visit, for a final assessment of the scar using the Patient and Observer Scar Assessment Scale (POSAS) system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Each participant scar was randomized to the 3 treatment arms.
| Arm | Type | Receives |
|---|---|---|
| 595nm PDL | Active comparator | Device: 595nm PDLOne third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
| 595/1064nm Multiplex Laser | Active comparator | Device: 595/1064nm Multiplex LaserOne third of the scar will be treated with 595/1064nm Multiplex laser for 3 weeks (1 treatment session per week). A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
| Control | No intervention | –One third of the scar will be left untreated for the duration of the study. A blinded observer will evaluate each third of the scar 4 weeks after the last treatment session using the POSAS system. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fitzpatrick skin types 1-3
- Suture line should be at least 3 cm long
Key exclusion criteria (4 listed)
- The patient should not be receiving any alternate systemic, topical or intralesional treatment of the scars during the study
- Pregnant or lactating females
- Fitzpatrick skin type 4-6
- A history of keloids or hypertrophic scars
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 |
|---|---|---|
| 595/1064nm Multiplex LaserThe multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL. | Device | 595/1064nm Multiplex Laser |
| 595nm PDLOne third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week). | Device | 595nm PDL |
Primary outcome
POSAS (The Patient and Observer Scar Assessment Scale) Measure
Time frame: 2 months
POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Keyvan Nouri, MD principal investigator
University of Miami Sylvester Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 595/1064nm Multiplex Laser and 595nm PDL in people with Scar, run by University of Miami at 1 site in United States.
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 21 Aug 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
POSAS (The Patient and Observer Scar Assessment Scale) Measure (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2018.