The intended use of the Alexandrite laser device used in this study is to assess the efficacy and safety of the Alexandrite laser device for the treatment of acne scars on skin types V and VI.
Subjects are to be enrolled in this clinical study if they are 18-65 years old. A maximum of 25 subjects will be enrolled at 1 study center. Subjects will receive up to 6 treatments (minimum of 4 treatment visits with an optional 5th and 6th treatment) on the face. Subjects will return for follow up visits at 30 and 90 days post last treatment. All subjects will receive a phone call 1 week after each treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Non-invasive radiofrequency Alexandrite laser
Wallace Skin and Body Institute
Los Angeles, California, United States
Laser & Skin Surgery Center of New York
New York, New York, United States
Photographic Evaluation of Changes in Treatment Areas
Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 90 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.
Time frame: Baseline and 90 day follow up
Photographic Evaluation of Treatment Areas
Photographic evaluation with ECCA (échelle d'évaluation clinique des cicatrices d'acné) grading comparing pre-treatment images to the 30 day follow up images performed by independent reviewers. This scale gives higher scores based on the number of scars, with the description of the scars determining the weighting factor. The scale ranges from 0 to 540, with a lower score meaning less severe scarring.
Time frame: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Blind identification of pre-treatment images vs. 30 day follow up images performed by independent reviewers.
Time frame: Baseline and 30 day follow up
Blinded evaluation of pre-treatment images vs. follow up images to determine which image is which
Blind identification of pre-treatment images vs. 90 day follow up images performed by independent reviewers.
Time frame: Baseline and 90 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 30 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
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Time frame: Baseline and 30 day follow up
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS)
Principle Investigator assessment using the Global Aesthetic Improvement Scale (PGAIS) at the 90 day follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Time frame: Baseline and 90 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 30 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Time frame: Baseline and 30 day follow up
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS)
Subject assessment using the Global Aesthetic Improvement Scale (SGAIS) at the 90 follow up visit. The GAIS scale ranges from 1 to 5, with 1 being "very much improved," 2 being "much improved," 3 being "improved," 4 being "no change," and 5 being "worse."
Time frame: Baseline and 90 day follow up
Subject satisfaction
Subject satisfaction rates at the 30 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.
Time frame: 30 day follow up
Subject satisfaction
Subject satisfaction rates at the 90 day follow up visit. The subject satisfaction scale ranges from 1 to 6, with 1 being extremely unsatisfied, 2 being dissatisfied, 3 being slightly unsatisfied, 4 being slightly satisfied, 5 being satisfied, and 6 being extremely satisfied.
Time frame: 90 day follow up