Wrinkles
Conditions
Keywords
Rhytids, Skin Laxity
Brief summary
Study is a prospective clinical trial to evaluate the efficacy of the Ulthera® System to improve Lifting Skin on the Neck. Changes from baseline in the FACE-Q Appraisal of Neck scale score and Global Aesthetic Improvement Scale scores will be assessed at study follow-up visits.
Detailed description
Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and all subjects will check the FACE-Q Appraisal of Neck scale score Treatment: The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200\ 260 lines of 3.0 and 4.5 probe respectively on the subject's neck. Post-Treatment: All subjects will visit the Institution at 12 weeks from the day of procedure, and will take photos of the neck. Efficacy evaluation will performed by the Photographic Evaluator.
Interventions
DEVICEUltherapy™ System
The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200\ 260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
Sponsors
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female, aged 30 to 65 years. * Subject in good health * Subjects who desire improvement in neck skin
Exclusion criteria
* Presence of an active systemic infectious disease * general disease or skin disorder in the area to be treated * Pregnant or lactating subjects * Previous episode of facial or neck surgery for wrinkle correction * Subjects who have aesthetic addiction, drug abuse, alcohol abuse * Subjects who were treated Botox or Filler at the neck area * Subjects who had Auto-Immune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of Improvement at 12 weeks post-treatment | 12 weeks post-treatment | Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessment of Improvement at 12 weeks post-treatment | 12 weeks post-treatment | Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment |
| Subjects' Assessment of Pain during treatment | Subjects were assessed for the duration of study treatment | Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible. |
Countries
South Korea
Outcome results
None listed