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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fraxel Laser | Device | One half of the scar is treated with Fraxel Laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Chitogopeker, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Health Care, Department of Dermatology | Iowa City | Iowa | 52242 | United States |
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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.
100 patients were recruited from the University of Iowa, Hospitals and Clinics between June to August 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scar is Treated With Fraxel 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blistering | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Superficial blisters on the skin following treatment with CO2 and Fraxel laser |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marta VanBeek | Univeristy of Iowa, Hospitals and Clinics | (319) 384-6012 | marta-vanbeek@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2017 | Nov 17, 2017 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 16, 2017 | Nov 17, 2017 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| CO2 Laser | Device | One half of the scar is treated with CO2 Laser. |
|
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. |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Scar age | Mean | Standard Deviation | years |
|
| Scar length | Mean | Standard Deviation | Centimeters |
|
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|
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| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| 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. | Patients with available data at the 6-month time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
|
| Primary | Patient Satisfaction | Patients rated how satisfied they were with the appearance of each half of the treated scar. | Participants with available data. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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). | Patients with available data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months. |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 3 |
| 100 |
| EG001 | Scar Treated With 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 CO2 Laser | 0 | 100 | 0 | 100 | 3 | 100 |
|
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
|
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| Somewhat dissatisfied |
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| Somewhat satisfied |
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| Satisfied |
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| Very Satisfied |
|
| Missing |
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