Scar
Conditions
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.
Interventions
DEVICEFraxel Laser
One half of the scar is treated with Fraxel Laser
DEVICECO2 Laser
One half of the scar is treated with CO2 Laser.
Sponsors
Marta Hemmingson-Van Beek
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Pain | 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. |
| Scar Itching | 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. |
| Scar Color | 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. |
| Scar Stiffness | 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. |
| Scar Thickness | 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. |
| Scar Irregularity | 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. |
| Overall Opinion | 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. |
| Patient Satisfaction | 6 months | Patients rated how satisfied they were with the appearance of each half of the treated scar. |
| Observer Total Score | 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). |
Countries
United States
Participant flow
Recruitment details
100 patients were recruited from the University of Iowa, Hospitals and Clinics between June to August 2016.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Scar is Treated With Fraxel Laser and CO2 Laser Fraxel Laser: One half of the scar is treated with Fraxel Laser
CO2 Laser: One half of the scar is treated with CO2 Laser. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 17 |
Baseline characteristics
| Characteristic | Scar is Treated With Fraxel Laser and CO2 Laser | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 97 Participants | — |
| Age, Continuous | 43.8 years STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 100 Participants | — |
| Scar age | 11.7 years STANDARD_DEVIATION 13.7 | — |
| Scar length | 12.1 Centimeters STANDARD_DEVIATION 9.1 | — |
| Sex: Female, Male Female | 80 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 3 / 100 | 3 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
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).
Time frame: Baseline and 6 months.
Population: Patients with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scar is Treated With Fraxel Laser | Observer Total Score | -0.3238 units on a scale | Standard Deviation 1.9781 |
| Scar Treated With CO2 Laser | Observer Total Score | 0.0586 units on a scale | Standard Deviation 2.0552 |
p-value: 0.0281t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Overall Opinion | Baseline | 6.695 units on a scale | Standard Deviation 2.215 |
| Scar is Treated With Fraxel Laser | Overall Opinion | 6 months | 4.024 units on a scale | Standard Deviation 2.049 |
| Scar Treated With CO2 Laser | Overall Opinion | Baseline | 6.654 units on a scale | Standard Deviation 2.265 |
| Scar Treated With CO2 Laser | Overall Opinion | 6 months | 4.207 units on a scale | Standard Deviation 2.187 |
p-value: 0.1752t-test, 2 sided
Primary
Patient Satisfaction
Patients rated how satisfied they were with the appearance of each half of the treated scar.
Time frame: 6 months
Population: Participants with available data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Somewhat satisfied | 18 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Very dissatisfied | 0 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Satisfied | 33 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Somewhat dissatisfied | 10 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Very Satisfied | 19 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Missing | 1 Participants |
| Scar is Treated With Fraxel Laser | Patient Satisfaction | Dissatisfied | 2 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Missing | 1 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Very dissatisfied | 0 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Dissatisfied | 3 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Somewhat dissatisfied | 9 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Somewhat satisfied | 23 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Satisfied | 28 Participants |
| Scar Treated With CO2 Laser | Patient Satisfaction | Very Satisfied | 19 Participants |
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Color | Baseline | 5.622 units on a scale | Standard Deviation 2.623 |
| Scar is Treated With Fraxel Laser | Scar Color | 6 months | 4.108 units on a scale | Standard Deviation 2.078 |
| Scar Treated With CO2 Laser | Scar Color | Baseline | 5.518 units on a scale | Standard Deviation 2.661 |
| Scar Treated With CO2 Laser | Scar Color | 6 months | 4.313 units on a scale | Standard Deviation 2.112 |
p-value: 0.0686t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Irregularity | Baseline | 6.602 units on a scale | Standard Deviation 2.888 |
| Scar is Treated With Fraxel Laser | Scar Irregularity | 6 months | 3.3964 units on a scale | Standard Deviation 2.167 |
| Scar Treated With CO2 Laser | Scar Irregularity | Baseline | 6.500 units on a scale | Standard Deviation 2.616 |
| Scar Treated With CO2 Laser | Scar Irregularity | 6 months | 4.084 units on a scale | Standard Deviation 2.199 |
p-value: 0.3418t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Itching | Baseline | 1.386 units on a scale | Standard Deviation 0.853 |
| Scar is Treated With Fraxel Laser | Scar Itching | 6 months | 1.084 units on a scale | Standard Deviation 0.568 |
| Scar Treated With CO2 Laser | Scar Itching | Baseline | 1.337 units on a scale | Standard Deviation 0.873 |
| Scar Treated With CO2 Laser | Scar Itching | 6 months | 1.277 units on a scale | Standard Deviation 1.14 |
p-value: 0.0817t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Pain | Baseline | 1.265 units on a scale | Standard Deviation 0.938 |
| Scar is Treated With Fraxel Laser | Scar Pain | 6 months | 1.048 units on a scale | Standard Deviation 0.215 |
| Scar Treated With CO2 Laser | Scar Pain | Baseline | 1.181 units on a scale | Standard Deviation 0.608 |
| Scar Treated With CO2 Laser | Scar Pain | 6 months | 1.084 units on a scale | Standard Deviation 0.474 |
p-value: 0.0492t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Stiffness | Baseline | 4.361 units on a scale | Standard Deviation 2.77 |
| Scar is Treated With Fraxel Laser | Scar Stiffness | 6 months | 3.313 units on a scale | Standard Deviation 2.112 |
| Scar Treated With CO2 Laser | Scar Stiffness | Baseline | 4.518 units on a scale | Standard Deviation 2.856 |
| Scar Treated With CO2 Laser | Scar Stiffness | 6 months | 3.386 units on a scale | Standard Deviation 2.094 |
p-value: 0.6278t-test, 2 sided
Primary
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.
Time frame: Baseline and 6 months
Population: Patients with available data at the 6-month time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Scar is Treated With Fraxel Laser | Scar Thickness | Baseline | 5.325 units on a scale | Standard Deviation 2.785 |
| Scar is Treated With Fraxel Laser | Scar Thickness | 6 months | 3.373 units on a scale | Standard Deviation 1.943 |
| Scar Treated With CO2 Laser | Scar Thickness | Baseline | 5.145 units on a scale | Standard Deviation 2.833 |
| Scar Treated With CO2 Laser | Scar Thickness | 6 months | 3.530 units on a scale | Standard Deviation 2.086 |
p-value: 0.0848t-test, 2 sided