To assess the efficacy of a 1064nm picosecond laser (PicoWay; Candela; Marlborough, MA) with diffractive lens array and a picosecond 755nm laser (PicoSure®; Cynosure®; Westford, MA) with diffractive lens array in subjects for the improvement of facial skin quality. Secondary objectives of this clinical trial are to assess whether the 1064nm or 755nm picosecond laser is more efficacious in improving facial skin quality, safety of the procedure, comfortability of the procedure, and subject satisfaction.
subject will be randomized to have either their right facial half or left facial half treated with the 1064nm picosecond laser with diffractive lens array. The contralateral facial half not randomized will be treated with the 755nm picosecond laser with diffractive lens array. Subjects will receive three (3) treatments, four (4) weeks ± 7 days apart to each facial half. For additional comfort, cold air cooling (Zimmer MedizinSystems, Irvine, CA) set on level 5 will be used throughout the treatment. After each treatment, subjects will be provided with CeraVe gentle facial cleanser (CeraVe; New York, NY) and CeraVe lotion (CeraVe; New York, NY) to be used twice daily for two weeks. Additionally, a mineral CeraVe sunscreen (CeraVe; New York, NY) will also be provided to subjects to be used every morning with reapplication every two (2) hours if going outside for the entirety of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.
There have been small studies demonstrating the use of picosecond lasers for treatment of wrinkles and skin laxity; however, there have been no studies investigating the use of picosecond lasers for the overall improvement in skin quality.
Scientific Assessment Scale of Skin Quality (SASSQ) to assess change
Scientific Assessment Scale of Skin Quality (SASSQ) (circle one) Elasticity 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Wrinkles 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Skin Surface Roughness 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Lentigines/ Pigmentation 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Erythema 0- No 1- Mild 2- Moderate 3- Severe 4- Very Severe Pore Size 0- Fine 1- Small 2- Moderate 3- Large 4- Very Large
Time frame: Screening, Baseline, Day 28, Day 56, Day 140
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change
Blinded Physician Global Aesthetic Improvement Scale Assessment (PGAIS) Rating Description 1. Very Much Improved: Optimal cosmetic result in this subject. 2. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3. Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change: The appearance is essentially the same as the original condition. 5. Worse: The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Left Facial Half Right Facial Half Not Treated Not Treated
Time frame: Day 28, Day 56, Day 140
Percent improvement of skin quality by blinded investigator to assess change
Blinded Investigator Percent Improvement Evaluation - Left Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%) Blinded Investigator Percent Improvement Evaluation - Right Facial Half Degree of improvement from clinical evaluation, compare to baseline, using a 1-10 scale. 1 (0-10%) 2 (10-20%) 3 (20-30%) 4(30-40%) 5 (40-50%) 6 (50-60%) 7 (60-70%) 8 (70-80%) 9 (80-90%) 10 (90-100%)
Time frame: Day 28, Day 56, Day 140
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Subject Global Aesthetic Improvement Scale (SGAIS)
Subject Global Aesthetic Improvement Scale Assessment (SGAIS) How would you rate the change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you. Rating Description 1. Very Much Improved: Optimal cosmetic result 2. Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal 3. Improved: Obvious improvement in appearance from initial condition 4. No Change: The appearance is essentially the same as the original condition 5. Worse: The appearance is worse than the original condition Scores (write a number to rate each treated area) Left Facial Half Right Facial Half Not Treated Not Treated
Time frame: Day 28, Day 56, Day 140
Subject Satisfaction Questionnaire
Subject Satisfaction Questionnaire How would you rate your satisfaction of each treated area? Non-treated areas will be checked as "Not Treated" for you. Rating Description 0 Not satisfied 1. Somewhat satisfied 2. Satisfied 3. Very satisfied 4. Extremely Satisfied Scores (write a number to rate each treated area) Left Facial Half Right Facial Half
Time frame: Day 140
Comfort level visual analog scale post-procedure by subjects
Visual Analog Scale - Left Facial Half Visual Analog Scale (Circle One) 1 2 3 4 5 6 7 8 9 10 Visual Analog Scale - Right Facial Half Visual Analog Scale (Circle One) 1 2 3 4 5 6 7 8 9 10
Time frame: Baseline, Day 28, Day 56
Evaluation of side effects and adverse effects by investigators
Treating Investigator Evaluation of Side Effects Rating Description 0 NONE: Normal 1. TRACE: Barely visible and localized 2. MILD: Somewhat visible and diffuse 3. MODERATE: Visible and diffuse 4. SEVERE: Extremely visible and dense SCORES (write number under each treated area or check "Not Treated") Erythema Left Facial Half Right Facial Half Edema Left Facial Half Right Facial Half Hyperpigmentation Left Facial Half Right Facial Half Hypopigmentation Left Facial Half Right Facial Half Bruising Left Facial Half Right Facial Half Ulcer Left Facial Half Right Facial Half
Time frame: Baseline, Day 28, Day 56, Day 140