Comparison of Lasers in the Treatment of Scars

Marta Hemmingson-Van Beek

Status: Completed

Conditions: Scar

Treatments: Device: Fraxel Laser; Device: CO2 Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02988622

201509722

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 or older.
2. Fitzpatrick skin type I-IV.
3. Scars secondary to surgery or trauma.
4. Scar length minimum 4 cm in length.

Exclusion criteria

1. Scars less than 6 weeks old.
2. History of keloid scarring.
3. Use of isotretinoin currently or within 3 months of enrollment
4. Use of photosensitive medication currently or within 3 months of enrollment.
5. Pregnancy -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Scar treated with Fraxel and CO2 laser

Other group

Description:

One half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser.

Treatment:

Device: CO2 Laser

Device: Fraxel Laser