Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Scars

Intervention / Treatment
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* Device: Pulsed dye laser treatment
* Device: CO2 laser treatment
* Device: Combined PDL and CO2 laser treatment
* Device: Split PDL and CO2 Laser treatment


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed Dye Laser treatment<br>Pulsed Dye Laser treatment after suture removal (3 sessions) | Device: Pulsed dye laser treatment<br>* Scar minimization with Pulsed dye laser treatment on suture removal day<br>* Other names: Vbeam, Vbeam Perfecta, PDL;|
| Active Comparator: CO2 laser treatment<br>CO2 laser (3 treatment sessions) after suture removal | Device: CO2 laser treatment<br>* Scar minimization with CO2 laser treatment on suture removal day<br>* Other names: CO2RE, CORE;|
| Active Comparator: Combined PDL and CO2 Laser treatment<br>Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal | Device: Combined PDL and CO2 laser treatment<br>* Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day<br>* Other names: Vbeam, Vbeam Perfecta, CO2RE, CORE;|
| Active Comparator: Split PDL and CO2 Laser treatment<br>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 | Device: Split PDL and CO2 Laser treatment<br>* Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline | Blinded review of 7-point Global Evaluation Response (GER) scale | Baseline, 3 months after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, 3 months after final treatment |