This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
UltraClear® is a 2,910 nm fractional ablative erbium-doped fluoride glass fiber laser (Acclaro), FDA 510(k) cleared (K210847, K233803) for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. In this study, it is applied to the lower face, submental region, and neck using fractional ablative resurfacing, laser-coring, and full ablative resurfacing configurations, with mode and parameters selected by the investigator based on baseline anatomy and tissue laxity.
Julene B Samuels MD, FACS
Prospect, Kentucky, United States
Dermatology & Laser Surgery Center
Houston, Texas, United States
Quantitative 2D Photographic Analysis:
Proportion of participants achieving a ≥20 mm² reduction in submental area post treatment, measured by a blinded independent analyst using a five-point landmark methodology applied to standardized 2D photographs. The study-level responder rate must achieve statistical significance (p \< 0.05).
Time frame: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Blinded Photographic Review
Proportion of participants for whom ≥2 of 3 Blinded Independent Photographic Reviewers (BIPRs) correctly identify post-treatment improvement from paired baseline and Visit 6 photographs of the submental and neck regions. Pre-specified responder threshold: ≥80% of evaluable participants.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Investigator Global Aesthetic Improvement Scale (iGAIS)
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Investigator Merz Jawline Grading Scale (MJGS)
Range: 0-4 Directionality: lower score equates to better outcome (less sagging) (0= No sagging, 1= Mild sagging, 2= Moderate sagging, 3= Severe sagging, 4= Very severe sagging). Change from baseline will be assessed.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Participant Global Aesthetic Improvement Scale (sGAIS)
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
FACE-Q™ Satisfaction with Lower Face and Jawline (Rasch-transformed score)
Range: 1-4, Directionality: higher score equates to increased satisfaction (1= Very dissatisfied, 2= Somewhat dissatisfied, 3= Somewhat satisfied, 4= Very satisfied). Change from baseline will be assessed.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Participant satisfaction questionnaire
Range: 1-4 Directionality: higher score equates to increased satisfaction (1= very dissatisfied, 2= Dissatisfied, 3= Satisfied, 4= Very satisfied). Satisfaction questionnaire completed by participant following two 2910 nm fiber laser treatments.
Time frame: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
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