NCT02988622

Comparison of Lasers in the Treatment of Scars

1550-nm Non Ablative Laser (Fraxel) Versus Ablative 10,600-nm Carbon Dioxide (CO2) Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy, Treatment Regimen, and Cost.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Marta Hemmingson-Van Beek · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Scar

Interventions

Type	Name	Description
DEVICE	Fraxel Laser	One half of the scar is treated with Fraxel Laser
DEVICE	CO2 Laser	One half of the scar is treated with CO2 Laser.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2016-12-09
• Last updated: 2018-10-18
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study