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Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated laser | Experimental | This Arm is the section of scar that will be treated with Fractionated Laser |
|
| Dermabrasion | Active Comparator | Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated laser | Device | Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe. | Day 0, Week1, Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Assessing Scar Improvement. | Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement
| 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J Christophel, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zel Skin and Laser | Edina | Minnesota | 55424 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22268699 | Derived | Jared Christophel J, Elm C, Endrizzi BT, Hilger PA, Zelickson B. A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing. Dermatol Surg. 2012 Apr;38(4):595-602. doi: 10.1111/j.1524-4725.2011.02283.x. Epub 2012 Jan 23. |
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Adult patients aged 18 and older were recruited from a reconstructive surgical practice. Preference was given to patients who had undergone interpolated axial flaps (e.g., forehead flaps) because this allowed treatment of two different scars on a single patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Scars | 12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion. The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal-epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Scars | 12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion. |
| 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 | Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing | Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe. | Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion. | Posted | Mean | Standard Error | units on a scale | Day 0, Week1, Month 1 | Scars | Scars |
|
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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 | Fractionated Laser | This Arm is the section of scar that will be treated with Fractionated Laser |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Jared Christophel MD | University of Virginia Dept of Otolaryngology Head and Neck Surgery | 434-243-9391 | jjchristop@gmail.com |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D003869 | Dermabrasion |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D062109 | Dermatologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
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| Dermabrasion | Device | Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Visual Analog Scale for Assessing Scar Improvement. | Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement
| With 12 pairs of scars gave a 95% probability to detect a treatment difference at a two sided 0.05 significance level if a significant difference between treatments is 1.5 units (based on a 0 -4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units. | Posted | Mean | Standard Deviation | units on a scale | 3 months | Scar Halves | Scar Halves |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Dermabrasion | Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. | 0 | 6 | 0 | 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013514 | Surgical Procedures, Operative |
| Non-Inferiority or Equivalence (legacy) |
With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units. |