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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 532nm KTP | Other | Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser |
|
| 595nm PDL | Active Comparator | Cynosure Cynergy 595nm pulsed-dye (PDL) laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 532nm KTP | Device | up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12-weeks post-final laser treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Alster, MD | Washington Institute of Dermatologic Laser Surgery | Principal Investigator |
| Elizabeth Tanzi, MD | Washington Institute of Dermatologic Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Institute of Dermatologic Laser Surgery | Washington D.C. | District of Columbia | 20005 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Patients with matched bilateral erythematous surgical scars or a single linear erythematous scar measuring longer than 5 cm were enrolled in the study. Single scars were divided into equal halves, with each half randomized to receive treatments with either a 532-nm KTP laser (Excel V; Brisbane, CA) or a 595-nm PDL (Cynergy; Cynosure Inc., Chelmsford, MA) at equivalent laser parameters. Bilateral matched scars were similarly randomized to receive 532-nm KTP or 595-nm PDL treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects treated with Cutera ExcelV 532nm KTP laser or Cynosure Cynergy 595nm pulsed-dye laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | 95% Confidence Interval | score on a scale | 12-weeks post-final laser treatment | Halves or single scars treated | Halves or single scars treated |
|
Adverse events were collected from the time of first laser treatment through completion of the study for all subjects (24 weeks)
Systematic assessment occurred through regular investigator assessments during study visits. Between visits, participants were also encouraged to contact the site to report any adverse events that occurred as applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 532nm KTP Laser | Cutera ExcelV 532nm KTP laser 532nm potassium titanyl phosphate (KTP) laser |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margot Doucette | Cutera | 415-657-5518 | mdoucette@cutera.com |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D017439 | Cicatrix, Hypertrophic |
| D007627 | Keloid |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
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| 595nm PDL | Device | up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| EG001 | 595nm PDL | Cynosure Cynergy 595nm pulsed-dye laser 595nm pulsed-dye laser (PDL) | 0 | 19 | 0 | 19 | 8 | 19 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Burning Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |