Trial Outcomes & Findings for Laser Resurfacing Versus Dermabrasion for Scar Revision (NCT NCT01176448)

Last Updated: 2019-11-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Day 0, Week1, Month 1

Results posted on

2019-11-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laser Resurfacing Versus Dermabrasion for Scar Revision

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Scars n=6 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.6 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0, Week1, Month 1

Population: Each scar was divided in half and the halves randomized to either Fractionated Laser treatment or Dermabrasion.

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.

Outcome measures

Outcome measures
Measure	Fractionated Laser n=12 Scars This Arm is the section of scar that will be treated with Fractionated Laser	Dermabrasion n=12 Scars Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Erythema Day 0	1.33 units on a scale Standard Error 0.49	3.00 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Edema Day 0	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Bleeding Day 0	1.08 units on a scale Standard Error 0.29	2.0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Eschar Day 0	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Erythema Week 1	0.75 units on a scale Standard Error 0.45	1.50 units on a scale Standard Error 0.52
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Edema Week 1	0.17 units on a scale Standard Error 0.39	0.50 units on a scale Standard Error 0.52
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Bleeding Week 1	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Eschar Week 1	0.08 units on a scale Standard Error 0.29	0.92 units on a scale Standard Error 0.79
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Erythema Month 1	0.38 units on a scale Standard Error 0.52	1.25 units on a scale Standard Error 1.04
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Edema Month 1	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Bleeding Month 1	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing Eschar Month 1	0 units on a scale Standard Error 0	0 units on a scale Standard Error 0

SECONDARY outcome

Timeframe: 3 months

Population: 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.

Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement 1. : 1-25% improvement 2. : 26-50% improvement 3. : 51-75% improvement 4. : 76-100% improvement

Outcome measures

Outcome measures
Measure	Fractionated Laser n=12 Scar Halves This Arm is the section of scar that will be treated with Fractionated Laser	Dermabrasion n=12 Scar Halves Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
Visual Analog Scale for Assessing Scar Improvement.	1.53 units on a scale Standard Deviation .59	1.49 units on a scale Standard Deviation .39

Adverse Events

Fractionated Laser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dermabrasion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Jared Christophel MD

University of Virginia Dept of Otolaryngology Head and Neck Surgery

Phone: 434-243-9391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place