ScarsNCT02898350
Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser
A study testing Pulsed dye laser treatment, CO2 laser treatment and Combined PDL and CO2 laser treatment in people with Scars, run by Syneron Medical at 2 sites in United States.
Trial summary
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Scars
- What is being tested?
- Pulsed dye laser treatment, CO2 laser treatment and Combined PDL and CO2 laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Sep 2016
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Comprehension of, and willingness to sign, the Informed Consent Form.
- Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
- Be a healthy male or female of at least 18 years old.
- Fitzpatrick skin type I-V.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
- Non pregnant and/or breast feeding, if applicable.
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- Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
- Agree to follow and undergo all study-related procedures.
- Use of daily use of sunblock SPF 30 or higher for duration of the study.
Who cannot join
- Pregnant and/or breastfeeding.
- Fitzpatrick skin type VI.
- Prior treatment for the surgical scar to be treated in this study.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of Isotretinoin or other systemic retinoids within the past 6 months.
- Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
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- Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
- Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
- Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AboutSkin, Dermatology and Derm Surgery PC
Englewood, Colorado, 80113
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Multi-Center Study to Compare the Safety and Efficacy of Clearance of Surgical Scars With the Pulse Dye Laser in Combination With a CO2 Laser in a Split Scar Evaluation
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.
Read the detailed description
Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.
- Conditions
- Scars
- Being tested
- Pulsed dye laser treatment, CO2 laser treatment, Combined PDL and CO2 laser treatment, Split PDL and CO2 Laser treatment
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laser treatmentDevice
Also called Vbeam, Vbeam Perfecta, PDL
Scar minimization with Pulsed dye laser treatment on suture removal day
CO2 laser treatmentDevice
Also called CO2RE, CORE
Scar minimization with CO2 laser treatment on suture removal day
Combined PDL and CO2 laser treatmentDevice
Also called Vbeam, Vbeam Perfecta, CO2RE, CORE
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
Split PDL and CO2 Laser treatmentDevice
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Dye Laser treatment | Active comparator | Pulsed Dye Laser treatment after suture removal (3 sessions) Receives: Device: Pulsed dye laser treatment |
| CO2 laser treatment | Active comparator | CO2 laser (3 treatment sessions) after suture removal Receives: Device: CO2 laser treatment |
| Combined PDL and CO2 Laser treatment | Active comparator | Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal Receives: Device: Combined PDL and CO2 laser treatment |
| Split PDL and CO2 Laser treatment | Active comparator | Half of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal Receives: Device: Split PDL and CO2 Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline
Blinded review of 7-point Global Evaluation Response (GER) scale
Measured: Baseline, 3 months after final treatment
Secondary outcomes (1)
Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline
Investigator review of VSS - The VSS assesses four variables: vascularity, pigmentation, pliability, and height of the scar, to provide an overall score from 0 (normal) to 13 (severe).
Measured: Baseline, 3 months after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ScarsStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, MSc, Study director, Syneron Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898350
- Sponsor's protocol ID
- DHF05911
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.
PubMed 24085055Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358.
PubMed 20157023Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. doi: 10.1046/j.1524-4725.2003.29024.x.
PubMed 12534508
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Study to Compare the Safety and Efficacy of Clearance of Surgical Scars With the Pulse Dye Laser in Combination With a CO2 Laser in a Split Scar Evaluation
- ClinicalTrials.gov ID
- NCT02898350
- Acronym / sponsor ID
- DHF05911
- Conditions
- Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Sep 2016 (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.
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.
Detailed description
Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulsed Dye Laser treatment | Active comparator | Device: Pulsed dye laser treatmentPulsed Dye Laser treatment after suture removal (3 sessions) |
| CO2 laser treatment | Active comparator | Device: CO2 laser treatmentCO2 laser (3 treatment sessions) after suture removal |
| Combined PDL and CO2 Laser treatment | Active comparator | Device: Combined PDL and CO2 laser treatmentCombined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal |
| Split PDL and CO2 Laser treatment | Active comparator | Device: Split PDL and CO2 Laser treatmentHalf of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Comprehension of, and willingness to sign, the Informed Consent Form.
- Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
- Be a healthy male or female of at least 18 years old.
- Fitzpatrick skin type I-V.
- Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
Key exclusion criteria (13 listed)
- Pregnant and/or breastfeeding.
- Fitzpatrick skin type VI.
- Prior treatment for the surgical scar to be treated in this study.
- Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- Use of Isotretinoin or other systemic retinoids within the past 6 months.
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 |
|---|---|---|
| Pulsed dye laser treatmentAlso: Vbeam, Vbeam Perfecta, PDLScar minimization with Pulsed dye laser treatment on suture removal day | Device | Pulsed Dye Laser treatment |
| CO2 laser treatmentAlso: CO2RE, COREScar minimization with CO2 laser treatment on suture removal day | Device | CO2 laser treatment |
| Combined PDL and CO2 laser treatmentAlso: Vbeam, Vbeam Perfecta, CO2RE, COREScar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day | Device | Combined PDL and CO2 Laser treatment |
| Split PDL and CO2 Laser treatmentSplit-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day | Device | Split PDL and CO2 Laser treatment |
Primary outcome
Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline
Time frame: Baseline, 3 months after final treatment
Blinded review of 7-point Global Evaluation Response (GER) scale
1 secondary outcome
Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline
Time frame: Baseline, 3 months after final treatment
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 14 Sep 2016.
- Background: PubMed 24085055Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.
- Background: PubMed 20157023Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358.
- Background: PubMed 12534508Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. doi: 10.1046/j.1524-4725.2003.29024.x.
- Individual participant dataSharing planned: Undecided
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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.
Shlomit Mann, MSc study director
Syneron Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser treatment, CO2 laser treatment and Combined PDL and CO2 laser treatment in people with Scars, run by Syneron Medical at 2 sites 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 9 inclusion and 13 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline (time frame: Baseline, 3 months after final treatment). 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 NCT02898350, which also lists 3 linked publications.
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 14 Sep 2016.