Comparison of Lasers in the Treatment of Scars

NCT02988622 | Completed Results FDA Device

• 1 other identifier: 201509722
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (1)

Scar treated with Fraxel and CO2 laser

OTHER

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

Device: Fraxel Laser; Device: CO2 Laser

Interventions

Fraxel Laser DEVICE

One half of the scar is treated with Fraxel Laser

Scar treated with Fraxel and CO2 laser

CO2 Laser DEVICE

One half of the scar is treated with CO2 Laser.

Scar treated with Fraxel and CO2 laser

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marta Hemmingson-Van Beek: lead

Study Sites (1)

University of Iowa Health Care, Department of Dermatology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

This is the largest split scar study comparing the C02 laser and Fraxel laser, however despite this the numbers are still relatively small overall. 100 patients were enrolled in teh study but only 83 completed the study.

Results Point of Contact

• Title: Dr. Marta VanBeek
• Organization: Univeristy of Iowa, Hospitals and Clinics

marta-vanbeek@uiowa.edu

(319) 384-6012

Study Officials

• Pooja Chitogopeker, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 9, 2016
• Study Start: January 1, 2016
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: October 18, 2018
• Results First Posted: December 8, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)