The primary objective of this clinical trial is to evaluate the safety and effectiveness of the 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) for non-invasive dermatological aesthetic treatment of three facial regions: eyebrow lift (Region 1), submental tissue lift (Region 2), and improvement of rhytids and skin laxity in the cheeks, midface, and jawline (Region 3).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Enrolled subjects will receive a series of two with an optional third 2,910 nm Fiber Laser treatments using fractional ablative resurfacing modes, laser-coring and full ablation addressing the full face and upper neck.
Objective measurement of maximal eyebrow lift according to quantitative 2D imaging.
Time frame: Six months following final treatment
Blinded Photographic Review
Blinded independent photographic review correct identification of pre-post image sequence for eyebrow lift, submental lift and improvement of lax skin in the lower face and submentum.
Time frame: Six months following final treatment
○ Objective measurement of lax submental tissue lift according to quantitative 2D imaging.
Time frame: Six months following final treatment
Physician rating on the Global Aesthetic Improvement Scale (PGAIS)
Physician graded aesthetic improvement, scored from photographs. Scale 0 - 4 with 4 being the most improved and 0 being worse than the original condition. 4 - Very much improved, optimal cosmetic result, very significant improvement 3 - Much improved, market improvement in appearance from the initial condition, but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a pretreatment is needed, moderate 1 - No change, the appearance is essential the same as the original condition in appearance from he initial condition 0 - Worse, the appearance is worse than the original condition, no improvement
Time frame: Six months following final treatment
Subjects rating on the Subject Global Aesthetic Improvement Scale & Satisfaction Questionnaire (SGAIS)
Subjects rate their perceived improvement of the treatment area on a 5 point scale. 4- Very Much Improved, optimal cosmetic result, very significant improvement 3 - Much Improved, marked improvement in appearance from he initial condition but not completely optimal, marked 2 - Improved, obvious improvement in appearance from the initial condition, but a re-treatment is needed, moderate 1 - No change, the appearance is essentially the same as the original condition in appearance from the initial condition 0 - Worse, the appearance is worse than the original condition, no improvement
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Time frame: Six months following final treatment