The purpose of this study is to compare the 1550-nm non-ablative Fraxel laser (referred to as Fraxel Laser in this application) to the ablative 10,600-nm carbon dioxide fractional laser (referred to as CO2 Laser in this application) to determine if one is superior to the other in improving the appearance of scars over a series of three treatments. In addition, the investigators hope to identify a more cost-effective method to improve the appearance of scars caused by surgery or trauma.
This study will be accomplished through a controlled split-scar study design whereby half of the scar will be treated with the Fraxel Laser and the other half of the scar will be treated with the CO2 Laser. This study is a blinded, prospective comparative, split-scar study whereby 100 participants will be recruited, enrolled and followed for a period of 9 months. The study population will include male and female participants, age 18 and over with scars secondary to surgery or trauma on any part of the body. The study will recruit participants with light colored skin, Fitzpatrick Type I-IV, because colored skin has a significantly higher risk of keloid scarring. The scar must measure a minimum of 4 cm in length to accommodate for the split-scar treatment. The participants will undergo laser treatments on Visit 1, Visit 2 and Visit 3 and each visit will be 4 weeks apart. The participants will return for evaluation and follow-up 3 months and 6 months following the last laser treatment. At each visit, photographs will be taken using identical camera settings, lighting and participant positioning. Evaluation of the scars will be completed by the participants and by blinded dermatology physicians. Participants will use a complete visual analogue scale at each visit, the Patient and Observer Scar Assessment Scale (POSAS) and a satisfaction score.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
One half of the scar is treated with Fraxel Laser
One half of the scar is treated with CO2 Laser.
University of Iowa Health Care, Department of Dermatology
Iowa City, Iowa, United States
Scar Pain
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Scar Itching
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Scar Color
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Scar Stiffness
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Scar Thickness
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Scar Irregularity
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
Time frame: Baseline and 6 months
Overall Opinion
Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.
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Time frame: Baseline and 6 months
Patient Satisfaction
Patients rated how satisfied they were with the appearance of each half of the treated scar.
Time frame: 6 months
Observer Total Score
Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).
Time frame: Baseline and 6 months.