Trial Outcomes & Findings for Comparison of Lasers in the Treatment of Scars (NCT NCT02988622)

NCT ID: NCT02988622

Last Updated: 2018-10-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2018-10-18

Participant Flow

100 patients were recruited from the University of Iowa, Hospitals and Clinics between June to August 2016.

The exclusion criteria included any scar less than 6 weeks old, a history of keloid scarring, use of isotretinoin or other photosensitizing medication at the time of the study or within the previous 3 months and if the patient was pregnant.

Participant milestones

Measure	Scar is Treated With Fraxel Laser and CO2 Laser Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser CO2 Laser: One half of the scar is treated with CO2 Laser.
Overall Study STARTED	100
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Scar is Treated With Fraxel Laser and CO2 Laser Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser CO2 Laser: One half of the scar is treated with CO2 Laser.
Overall Study Lost to Follow-up	17

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Scar is Treated With Fraxel Laser and CO2 Laser n=100 Participants Fraxel Laser: One half of the scar is treated with Fraxel Laser CO2 Laser: One half of the scar is treated with CO2 Laser.
Age, Categorical <=18 years	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=100 Participants
Age, Categorical >=65 years	3 Participants n=100 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 13.0 • n=100 Participants
Sex: Female, Male Female	80 Participants n=100 Participants
Sex: Female, Male Male	20 Participants n=100 Participants
Region of Enrollment United States	100 Participants n=100 Participants
Scar age	11.7 years STANDARD_DEVIATION 13.7 • n=100 Participants
Scar length	12.1 Centimeters STANDARD_DEVIATION 9.1 • n=100 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Pain Baseline	1.265 units on a scale Standard Deviation 0.938	1.181 units on a scale Standard Deviation 0.608
Scar Pain 6 months	1.048 units on a scale Standard Deviation 0.215	1.084 units on a scale Standard Deviation 0.474

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Itching Baseline	1.386 units on a scale Standard Deviation 0.853	1.337 units on a scale Standard Deviation 0.873
Scar Itching 6 months	1.084 units on a scale Standard Deviation 0.568	1.277 units on a scale Standard Deviation 1.140

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Color Baseline	5.622 units on a scale Standard Deviation 2.623	5.518 units on a scale Standard Deviation 2.661
Scar Color 6 months	4.108 units on a scale Standard Deviation 2.078	4.313 units on a scale Standard Deviation 2.112

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Stiffness Baseline	4.361 units on a scale Standard Deviation 2.770	4.518 units on a scale Standard Deviation 2.856
Scar Stiffness 6 months	3.313 units on a scale Standard Deviation 2.112	3.386 units on a scale Standard Deviation 2.094

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Thickness Baseline	5.325 units on a scale Standard Deviation 2.785	5.145 units on a scale Standard Deviation 2.833
Scar Thickness 6 months	3.373 units on a scale Standard Deviation 1.943	3.530 units on a scale Standard Deviation 2.086

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Scar Irregularity Baseline	6.602 units on a scale Standard Deviation 2.888	6.500 units on a scale Standard Deviation 2.616
Scar Irregularity 6 months	3.3964 units on a scale Standard Deviation 2.167	4.084 units on a scale Standard Deviation 2.199

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Patients with available data at the 6-month time point.

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.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Overall Opinion Baseline	6.695 units on a scale Standard Deviation 2.215	6.654 units on a scale Standard Deviation 2.265
Overall Opinion 6 months	4.024 units on a scale Standard Deviation 2.049	4.207 units on a scale Standard Deviation 2.187

PRIMARY outcome

Timeframe: 6 months

Population: Participants with available data.

Patients rated how satisfied they were with the appearance of each half of the treated scar.

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=83 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=83 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Patient Satisfaction Very dissatisfied	0 Participants	0 Participants
Patient Satisfaction Dissatisfied	2 Participants	3 Participants
Patient Satisfaction Somewhat dissatisfied	10 Participants	9 Participants
Patient Satisfaction Somewhat satisfied	18 Participants	23 Participants
Patient Satisfaction Satisfied	33 Participants	28 Participants
Patient Satisfaction Very Satisfied	19 Participants	19 Participants
Patient Satisfaction Missing	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months.

Population: Patients with available data.

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).

Outcome measures

Measure	Scar is Treated With Fraxel Laser n=83 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=83 Participants Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Observer Total Score	-0.3238 units on a scale Standard Deviation 1.9781	0.0586 units on a scale Standard Deviation 2.0552

Adverse Events

Scar is Treated With Fraxel Laser

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Scar Treated With CO2 Laser

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Scar is Treated With Fraxel Laser n=100 participants at risk Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with Fraxel Laser	Scar Treated With CO2 Laser n=100 participants at risk Each patient received treatment with both lasers to separate halves of their scar. Fraxel Laser: One half of the scar is treated with CO2 Laser
Skin and subcutaneous tissue disorders Blistering	3.0% 3/100 • Number of events 3 • 6 months	3.0% 3/100 • Number of events 3 • 6 months

Additional Information

Dr. Marta VanBeek

Univeristy of Iowa, Hospitals and Clinics

Phone: (319) 384-6012

Email: marta-vanbeek@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place