PDL and Fractional Photothermolysis for Postsurgical Scars

Study Overview
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Brief Summary
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This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis. Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design. The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. This study is a pilot study designed to determine feasibility of this procedure.

Official Title
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The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars

Conditions
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Scar

Intervention / Treatment
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* Device: PDL (Pulsed Dye Laser)
* Device: Fractional Photothermolysis Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥ 18 years old Fitzpatrick skin types I-VI Subjects are in good health as judged by the investigator. Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks. Subjects applying topical retinoids, must discontinue one week prior to treatment. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. Exclusion Criteria: History of recurrent facial or labial herpes simplex infection Subjects applying topical retinoids, must discontinue one week prior to treatment. Subjects with a history of hypertrophic scars or keloids Pregnant or breast feeding Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. Subjects who are unable to understand the protocol or give informed consent. Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDL (Pulsed Dye Laser) and Fractional Photothermolysis<br> | Device: PDL (Pulsed Dye Laser)<br>* For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.<br>* Other names: Pulsed Dye Laser;Device: Fractional Photothermolysis Laser<br>* For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.<br>* Other names: Fraxel Laser;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of Patient and Observer Scar Assessment Scale (POSAS) | The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as not at all or normal skin and 10 as very much so or very different. | Baseline and 6 Months |