To assess efficacy and safety of paired picosecond 755nm Alexandrite laser with focused lens array (PSAL; Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (RFM; Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scars.
The primary objective of this clinical trial is to assess efficacy and safety of combination treatment with fractional picosecond 755nm Alexandrite laser with focused lens array (Picosure®, Cynosure, Westford, MA) and radiofrequency microneedling (Potenza™, Cynosure, Westford, MA) for treatment of facial, atrophic acne scarring. Enrolled subjects will be randomized to receive picosecond 755 nm Alexandrite laser treatment to either the left or right facial half. The subjects will then undergo full face radiofrequency microneedling (RFM). Subjects satisfying all inclusion and no exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory digital photographs will be obtained of each subject's treatment area. In order to participate in the study, subjects must provide written informed consent to have their photographs used for research, publication, and/or commercial purposes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime
Fractionated picosecond technology has been shown to lead to statistically significant improvement in atrophic, facial acne scars after 4-6 treatment sessions with minimal pain or downtime
Volumetric analysis of change in treatment zone for acne scars using 3D imaging
3D photography will be taken Standardized 3D Vectra Photography with standard lighting and camera positioning to ensure comparable before and after treatment photographs of the face. Photographs will be taken, capturing three (3) views of the hip area: anterior, right oblique (45°), and left oblique (45°). 3D photography is taken at every time frame to compare the appearance of acne scars to the previous photo.
Time frame: Baseline, Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271
ECCA acne grading scale by blinded investigator to assess change
Blinded Investigator ECCA (échelle d'évaluation clinique des cicatrices d'acné) acne grading scale V-Shaped atrophic scars, diameter of less than 2mm, and punctiform 0= no scar 1. a few scars 2. limited number of scars 3. many scars U-shaped atropic scars, diameter of 2-4 mm, with sheer edges 0= no scar 1. a few scars 2. limited number of scars 3. many scars M-shaped atrophic scars, diameter of more than 4mm, superficial and with irregular surface 0= no scar 1. a few scars 2. limited number of scars 3. many scars Superficial elastolysis 0= absent 1. mild 2. moderate 3. intense Hypertrophic inflammatory scars, scars of less than 2 years of age 0= no scar 1. a few scars 2. limited number of scars 3. many scars Keloid scars, hypertrophic scars, of more than 2 years of age 0= no scar 1. a few scars 2. limited number of scars 3. many scars
Time frame: Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271
Physician Global Aesthetic Improvement Scale (PGAIS) by blinded investigator
Blinded Investigator 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
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Time frame: Day 35, Day 63, Day 91, Day 121, Day 181, Day 271
Blinded Identification of correct treatment area by blinded investigator
The baseline (Day 0) and 6 month (Day 259) photographs will be randomly put side-by-side and labeled either (A) or (B). The blinded investigator will then fill out the following: 1. Do you see an improvement in photoaging between the two sets of photos? (Yes / No) 2. If yes to question #1: 1. Which is the post-treatment photograph? (A / B) 2. Which is the treatment side? (Right / Left)
Time frame: Day 271
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 35, Day 63, Day 91, Day 121, Day 181, Day 271
Evaluation of side 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 Not Treated Not Treated Edema Left Facial Half Left Facial Half Not Treated Not Treated Bruising/Petechiae Left Facial Half Left Facial Half Not Treated Not Treated Ulcers Left Facial Half Left Facial Half Not Treated Not Treated Hyperpigmentation/Hypopigmentation Left Facial Half Left Facial Half Not Treated Not Treated
Time frame: Day 7, Day 35, Day 63, Day 91, Day 121, Day 181, Day 271
Ultrasound imaging measurements of dermal edema
Treating investigator measurement of Sub-Dermal Edema by ultrasonography Treating Investigator Measurement of Sub-Dermal Edema by Ultrasonography Depth of dermis (mm) Ultrasound images will be obtained at the point of intersection when a horizontal line is drawn from the ala to the tragus and a vertical line is drawn from the lateral canthus to the lateral oral commissure. Left Facial Half Right Facial Half
Time frame: Day 7, Day 35, Day 63, Day 91