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.

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.

Study Overview

• Status: Completed
• Conditions: Scar
• Intervention / Treatment: Device: Fraxel Laser; Device: CO2 Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health Care, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Scar treated with Fraxel and CO2 laser; One half of scar is treated with Fraxel laser and the other half of scar is treated with CO2 laser.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline and 6 months
Patient Satisfaction	Patients rated how satisfied they were with the appearance of each half of the treated scar.	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).	Baseline and 6 months.

Collaborators and Investigators

• Sponsor: Marta Hemmingson-Van Beek
• Investigators: Principal Investigator: Pooja Chitogopeker, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201509722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes