Comparison of Lasers in the Treatment of Scars

• ClinicalTrials.gov Identifier: NCT02988622
• Recruitment Status: Completed
• First Posted: December 9, 2016
• Results First Posted: December 8, 2017
• Last Update Posted: October 18, 2018
• Sponsor: Marta Hemmingson-Van Beek
• Information provided by (Responsible Party): Marta Hemmingson-Van Beek, University of Iowa

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Scar	Device: Fraxel Laser; Device: CO2 Laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: January 2016
• Actual Primary Completion Date: January 15, 2018
• Actual Study Completion Date: January 15, 2018

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Scar Pain [ Time Frame: Baseline and 6 months ]
   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.
2. Scar Itching [ Time Frame: Baseline and 6 months ]
   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.
3. Scar Color [ Time Frame: Baseline and 6 months ]
   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.
4. Scar Stiffness [ Time Frame: Baseline and 6 months ]
   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.
5. Scar Thickness [ Time Frame: Baseline and 6 months ]
   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.
6. Scar Irregularity [ Time Frame: Baseline and 6 months ]
   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.
7. Overall Opinion [ Time Frame: Baseline and 6 months ]
   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.
8. Patient Satisfaction [ Time Frame: 6 months ]
   Patients rated how satisfied they were with the appearance of each half of the treated scar.
9. Observer Total Score [ Time Frame: Baseline and 6 months. ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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 -

Contacts and Locations

Locations

United States, Iowa

University of Iowa Health Care, Department of Dermatology

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Marta Hemmingson-Van Beek

Investigators

• Principal Investigator: Pooja Chitogopeker, MD; University of Iowa

  Study Documents (Full-Text)

Documents provided by Marta Hemmingson-Van Beek, University of Iowa:

Statistical Analysis Plan  [PDF] April 18, 2017

Study Protocol  [PDF] November 16, 2017

More Information

• Responsible Party: Marta Hemmingson-Van Beek, Sponsor Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT02988622
• Other Study ID Numbers: 201509722
• First Posted: December 9, 2016
• Results First Posted: December 8, 2017
• Last Update Posted: October 18, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes