This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20 subjects will receive study treatments. Following study treatments, follow-up visits will occur at 60, 90 and 180 days from each subject's last study treatment.
Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive up to three dual-depth treatments to the cheek and temple areas impacted by acne scars, treating the number of treatment squares necessary to cover the area of scarring. Each treatment square will receive 30 lines per transducer depth for a total of 60 lines per treatment square. Three treatments 30 days apart will be required.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Microfocused ultrasound treatment
Clinical Testing of Beverly Hills
Beverly Hills, California, United States
The Maas Clinic
San Francisco, California, United States
Acne Scar Improvement Scale
Determined by a masked, qualitative assessment of photographs at 90 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Time frame: 90 Days post-treatment #3
Acne Scar Improvement Scale
Determined by a masked, qualitative assessment of photographs at 180 days post final treatment compared to baseline. Clinical improvement will be assessed by the investigator from the visual of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Time frame: 180 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 60 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Time frame: 60 days post-treatment #3
Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 90 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Time frame: 90 days post-treatment #3
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Physician Scar Improvement Scale (PSIS) and Self-Assessed Scar Improvement Scale (SASIS)
Determined by PSIS (clinician) assessment and SASIS (subject) assessment at 180 days post final treatment compared to baseline. Clinical improvement will be assessed from the visual assessment of the treated area according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement.
Time frame: 180 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 60 days following the final study treatment to the baseline grade.
Time frame: 60 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 90 days following the final study treatment to the baseline grade.
Time frame: 90 days post-treatment #3
Physician Acne Scar Assessment Scale
Severity of acne scarring is are graded on a 5-point scale (0-4), where 0 = clear, 1= very mild, 2= mild, 3= moderate, 4= severe, comparing the grade assessed at 180 days following the final study treatment to the baseline grade.
Time frame: 180 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 60 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: 1. \- Very Much Improved 2. \- Much Improved 3. \- Improved 4. \- No Change 5. \- Worse
Time frame: 60 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 90 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: 1. \- Very Much Improved 2. \- Much Improved 3. \- Improved 4. \- No Change 5. \- Worse
Time frame: 90 days post-treatment #3
Clinician Global Aesthetic Improvement Scale (CGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS)
Overall aesthetic improvement assessed based on a live assessment of the subject and a photographic assessment comparing 180 day post-treatment photos to baseline photos. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows: 1. \- Very Much Improved 2. \- Much Improved 3. \- Improved 4. \- No Change 5. \- Worse
Time frame: 180 days post-treatment #3
Patient Satisfaction Questionnaire (PSQ)
Patient satisfaction determined by scores on a PSQ completed at 90 days post-treatment #3, indicating improvement in the areas treated and characterizing satisfaction with study treatment, i.e., Extremely Satisfied, Satisfied, Slightly Satisfied, Neither Satisfied or Dissatisfied, Slightly Dissatisfied, Dissatisfied, Extremely Dissatisfied.
Time frame: 90 days post-treatment #3