Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.

Conditions
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Scar, Surgical Scar, Cicatrix, Cicatrix, Hypertrophic, Keloid

Intervention / Treatment
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* Device: 532nm KTP
* Device: 595nm PDL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 532nm KTP<br>Cutera ExcelV 532nm potassium titanyl phosphate (KTP) laser | Device: 532nm KTP<br>* up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.<br>* Other names: Excel V;|
| Active Comparator: 595nm PDL<br>Cynosure Cynergy 595nm pulsed-dye (PDL) laser | Device: 595nm PDL<br>* up to three treatments of 1/2 of Single scar, or one entire, randomized Bilateral scar.<br>* Other names: Cynergy laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, Scar, Scars, Surgical Scar, Surgical Scars, Cicatrix, Hypertrophic Cicatrix, Keloid, Hypertrophic Scar, Surgical Incision, Scarring, Tummy Tuck, Augmentation Mammoplasty, Breast Augmentation, Thyroidectomy