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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Treatment Arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2,910 nm mid-infrared erbium-doped fluoride fiber glass laser (UltraClear, Acclaro Medical) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective measurement of maximal eyebrow lift according to quantitative 2D imaging. | 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. | Six months following final treatment |
| â—‹ Objective measurement of lax submental tissue lift according to quantitative 2D imaging. | Six months following final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pain and discomfort after treatment as reported by the subject on a visual analog scale (VAS) | VAS is a 10 point scale, reported by the subject. Subjects will be asked to report on a scale of 0-10, the average level of discomfort experienced during treatment. 0 - No Pain 5 - Moderate Pain 10 - Unbearable Pain | Periprocedural and 15 minutes post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| 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 | Six months following final treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |