Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 15, 2016
April 1, 2016
6 months
February 15, 2015
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator Assessment of Improvement at 12 weeks post-treatment
Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs
12 weeks post-treatment
Secondary Outcomes (2)
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
Study Arms (1)
Ultherapy™ System
EXPERIMENTALUltherapy™ System
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female, aged 30 to 65 years.
- Subject in good health
- Subjects who desire improvement in neck skin
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ChangSik Pak, Bachelor
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2015
First Posted
February 23, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
April 15, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share