This study is being conducted to evaluate the performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars. Participants will be treated with the MIRIA laser at least 4 times with each treatment spaced 4-6 weeks apart. The improvement of acne scars will be evaluated at 1 month and 3 months with a possibility of 6 months evaluation after the fourth treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
4-6 experimental treatments at 4-6 weeks intervals
Enchantress Dermatology
Miami, Florida, United States
AVAVA, Inc.
Waltham, Massachusetts, United States
Laser and Skin Surgery Center of New York
New York, New York, United States
ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score ECCA Global Score Limits: Lowest Score (0) to Highest Score (540)
Time frame: 3 months after the final treatment, Optional 6 months after final treatment
Blinded Evaluation of Treatment Imaging
Panel of independent expert grader dermatologists will review randomized photo sets of pre- and post-treatment imaging and asked to identify the post-treatment image.
Time frame: From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment
Physician Global Aesthetic Improvement Scale Scoring
Primary physician for the investigative site will review post-treatment imaging and score the improvement seen in the photos based on the below scale. 5 - Much Improved 4 - Improved 3 - No Change 2 - Worse 1 - Much Worse
Time frame: Up to 3 months after the final treatment, Optional up to 6 months after final treatment
Treatment Pain Assessment
Treatment Pain will be assessed at all treatment visits on a standard Visual Analog Scale Ranging from a score of 0 (no pain) to 10 (maximum possible pain)
Time frame: Through study completion, an average of 12 months
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