Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkles
- Sponsor
- Seoul National University Hospital
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Investigator Assessment of Improvement at 12 weeks post-treatment
- Status
- Completed
- Last Updated
- 10 years ago
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: 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.
Investigators
Eligibility Criteria
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)