Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Investigator Assessment of Improvement at 12 weeks post-treatment
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Investigator Assessment of Improvement at 12 weeks post-treatment
Time Frame: 12 weeks post-treatment
Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs
Secondary Outcomes
- Subject Assessment of Improvement at 12 weeks post-treatment(12 weeks post-treatment)
- Subjects' Assessment of Pain during treatment(Subjects were assessed for the duration of study treatment)