A Prospective, Single-center, Double-blinded, Randomized, Split-face Study Evaluating 1064nm Versus 755nm Picosecond Lasers With Diffractive Lens Array for Improvement of Skin Quality
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Enrollment
- 20
- Primary Endpoint
- Percent improvement of skin quality by blinded investigator to assess change
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
the blinded investigator will complete the Scientific Assessment Scale of Skin Quality (SASSQ). , the blinded investigator will complete the Physician Global Aesthetic Improvement Scale (PGAIS) and percent improvement evaluation. Percent Improvement Evaluation by Blinded investigator .
Subjects are blinded to which side receives which laser
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult males and females aged 18 to 65 years
- •Fitzpatrick skin types I-VI
- •Subjects in good general health based on investigator's judgment and medical history
- •Must be willing to give and sign an informed consent form and photographic release form
- •Willingness to have facial exams and digital photographs performed of the face
- •Physician evaluator classifying the subject as moderate or severe in all categories of the Scientific Assessment Scale of Skin Quality (SASSQ): elasticity, wrinkles, skin surface roughness, lentigines/pigmentation, erythema, blemishes, and pore size
- •No change in topical skin care regimen for duration of study
- •Must be willing to maintain usual sun exposure
- •Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
- •Negative urine pregnancy test result at the time of study entry (if applicable)
Exclusion Criteria
- •Mesotherapy, dermal fillers, biostimulatory injectables, and/or fat grafting in the treatment area during the 12-month period before study treatment
- •Energy-based device (i.e., radiofrequency device treatments, microfocused ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment area in the last 6 months
- •Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction to the neck and/or submentum, etc.) during the 12-month period before study treatment
- •Chemical peel or microdermabrasion of the face within 30 days prior to enrollment in the study
- •Any investigational treatment for improvement of skin quality and/or photodamage of facial skin during the 12-month period before the study treatment
- •Recent use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5- fluorouracil, ingenol mebutate, concentrated hydrogen peroxide or diclofenac to the face within the previous 2 weeks
- •Creams/cosmeceuticals and/or home therapies to prevent or treat photodamage, uneven skin pigmentation, excessive erythema (redness), fine lines/wrinkles, skin laxity and/or pore size during the 4-week period before study treatment
- •Subjects with scarring in the treatment areas
- •Subjects with tattoos or permanent implants in the treatment areas
- •Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
Outcomes
Primary Outcomes
Percent improvement of skin quality by blinded investigator to assess change
Time Frame: Day 28, Day 56, Day 140
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%)
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator to assess change
Time Frame: Day 28, Day 56, Day 140
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
Scientific Assessment Scale of Skin Quality (SASSQ) to assess change
Time Frame: Screening, Baseline, Day 28, Day 56, Day 140
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
Secondary Outcomes
- Comfort level visual analog scale post-procedure by subjects(Baseline, Day 28, Day 56)
- Subject Satisfaction Questionnaire(Day 140)
- Subject Global Aesthetic Improvement Scale (SGAIS)(Day 28, Day 56, Day 140)
- Evaluation of side effects and adverse effects by investigators(Baseline, Day 28, Day 56, Day 140)