Laser Treatment to Improve Skin Quality

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Quality
• Intervention / Treatment: Device: 1064NM pico Laser; Device: 755NM pico Laser

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

• For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.

  1. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
  2. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
• Must be willing to comply with study treatments and complete the entire course of the study

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
• Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
• Skin with open wounds, excessively sensitive skin, neurotic excoriations, dermatitis or inflammatory rosacea in the treatment area
• History of keloid or hypertrophic scarring
• Subjects with an active bacterial, viral, or fungal infection of the treatment areas
• Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
• History of lidocaine and/or tetracaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
• Individuals with known allergies or sensitivities to any of the ingredients of any topical products being used in this study
• Subjects on systemic steroids (i.e., prednisone, dexamethasone), or topical steroids on the face which should be rigorously avoided prior to and throughout the course of treatment
• Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
• Presence of incompletely healed wound(s) in the treatment area
• Subjects who are on an immunosuppressant or have an autoimmune condition
• Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A = right side face treated with 1064nm and left with 755nm; subject will have their right half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, left half 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.	Device: 1064NM pico Laser; 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.; Other Names: Candela 1064NM Laser; Device: 755NM pico Laser; 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.; Other Names: Cynosure 755NM Laser
Experimental: Group B = left side face treated with 1064nm and right with 755nm; subject will have their left half of their face treated with the 1064nm picosecond laser with diffractive lens array. Then the contralateral, right half 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.	Device: 1064NM pico Laser; 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.; Other Names: Candela 1064NM Laser; Device: 755NM pico Laser; 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.; Other Names: Cynosure 755NM Laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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; Very Much Improved: Optimal cosmetic result in this subject.; Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.; Improved: Obvious improvement in appearance from initial condition, but a re- treatment is indicated.; No Change: The appearance is essentially the same as the original condition.; 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	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%)	Day 28, Day 56, Day 140

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Very Much Improved: Optimal cosmetic result; Much Improved: Marked improvement in appearance form the initial condition, but not completely optimal; Improved: Obvious improvement in appearance from initial condition; No Change: The appearance is essentially the same as the original condition; 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	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; Somewhat satisfied; Satisfied; Very satisfied; Extremely Satisfied Scores (write a number to rate each treated area) Left Facial Half Right Facial Half	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	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; TRACE: Barely visible and localized; MILD: Somewhat visible and diffuse; MODERATE: Visible and diffuse; 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	Baseline, Day 28, Day 56, Day 140

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: wrinkles; sun spots; fine lines; laxity; facial laxity
• Other Study ID Numbers: Pico-Skin-Quality-2022-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes