Comparison of Lasers in the Treatment of Scars

NCT ID: NCT02988622

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-15

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Fraxel Laser

Intervention Type: DEVICE

One half of the scar is treated with Fraxel Laser

CO2 Laser

Intervention Type: DEVICE

One half of the scar is treated with CO2 Laser.

Interventions

Fraxel Laser

One half of the scar is treated with Fraxel Laser

Intervention Type: DEVICE

CO2 Laser

One half of the scar is treated with CO2 Laser.

Intervention Type: DEVICE

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marta Hemmingson-Van Beek

OTHER

Sponsor Role: lead

Responsible Party

Marta Hemmingson-Van Beek

Sponsor Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Pooja Chitogopeker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Health Care, Department of Dermatology

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

201509722

Identifier Type: -

Identifier Source: org_study_id