Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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