ScarNCT01789346
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
A study testing 532nm KTP and 595nm PDL in people with Scar and Surgical Scar, run by Cutera Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scar, Surgical Scar, Cicatrix
- What is being tested?
- 532nm KTP and 595nm PDL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I - IV
- Has postoperative linear scar(s) which is one to twelve months post-surgery.
- Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
- Be in good health.
- Must agree not to undergo any other procedure for the treatment of scar during the study.
- Willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period).
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- Able to read, understand and sign the Informed Consent Form.
- Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
- Willingness to have digital photographs taken of the treated scar.
- Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
Who cannot join
- Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
- Having received any prior treatment for the target surgical scar.
- Pregnant and/or breastfeeding.
- Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
- Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication.
- History of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
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- History of malignant skin disease, immune deficiency disorders, coagulation disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment.
- Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation.
- Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
- Current smoker or history of smoking within 12 months of study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Institute of Dermatologic Laser Surgery
Washington D.C., District of Columbia, 20005
About this study
Official title: Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
Read the detailed description
Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.
- Conditions
- Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic, Keloid
- Being tested
- 532nm KTP, 595nm PDL
- Keywords
- Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar, Surgical Incision, Scarring, Abdominoplasty, Tummy Tuck, Augmentation Mammoplasty, Breast Augmentation, Thyroidectomy
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic, Keloid, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532nm KTPDevice
Also called ExcelV laser, Cutera ExcelV, Excel V
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
595nm PDLDevice
Also called Cynosure Cynergy, Cynergy laser
up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.
| Study group | Role | What they receive |
|---|---|---|
| 532nm KTP | Other | Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser Receives: Device: 532nm KTP |
| 595nm PDL | Active comparator | Cynosure Cynergy 595nm pulsed-dye (PDL) laser Receives: Device: 595nm PDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
Improvement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome
Measured: 12-weeks post-final laser treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion26 Mar 2014
- Study completionDec 2014
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Alster, MD, Principal investigator, Washington Institute of Dermatologic Laser SurgeryElizabeth Tanzi, MD, Principal investigator, Washington Institute of Dermatologic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789346
- Sponsor's protocol ID
- C-12-EV03
- Status last verified
- Jan 2023
- First submitted
- 7 Feb 2013
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
- ClinicalTrials.gov ID
- NCT01789346
- Acronym / sponsor ID
- C-12-EV03
- Conditions
- Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic, Keloid
- Keywords
- Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cutera Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- 26 Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
Detailed description
Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 532nm KTP | Other | Device: 532nm KTPCutera ExcelV 532nm potassium titanyl phosphate (KTP) laser |
| 595nm PDL | Active comparator | Device: 595nm PDLCynosure Cynergy 595nm pulsed-dye (PDL) laser |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fitzpatrick Skin Type I - IV
- Has postoperative linear scar(s) which is one to twelve months post-surgery.
- Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
- Be in good health.
- Must agree not to undergo any other procedure for the treatment of scar during the study.
Key exclusion criteria (10 listed)
- Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
- Having received any prior treatment for the target surgical scar.
- Pregnant and/or breastfeeding.
- Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
- Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medication.
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 |
|---|---|---|
| 532nm KTPAlso: ExcelV laser, Cutera ExcelV, Excel Vup to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar. | Device | 532nm KTP |
| 595nm PDLAlso: Cynosure Cynergy, Cynergy laserup to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar. | Device | 595nm PDL |
Primary outcome
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
Time frame: 12-weeks post-final laser treatment
Improvement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
Tina Alster, MD principal investigator
Washington Institute of Dermatologic Laser Surgery
Elizabeth Tanzi, MD principal investigator
Washington Institute of Dermatologic Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 532nm KTP and 595nm PDL in people with Scar and Surgical Scar, run by Cutera Inc. 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 10 inclusion and 10 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 Feb 2023. 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 Feb 2023). 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?
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms. (time frame: 12-weeks post-final laser treatment). 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 Feb 2023.