Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin on the Neck

Clinical Trial to Evaluate Safety and Efficacy of Ultherapy™ System for Lifting Skin

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.

Study Overview

• Status: Completed
• Conditions: Wrinkles
• Intervention / Treatment: Device: Ultherapy™ System

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do,
    • Seongnam-si, Gyeonggi-do,, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultherapy™ System	Device: Ultherapy™ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Assessment of Improvement at 12 weeks post-treatment	Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment	12 weeks post-treatment
Subjects' Assessment of Pain during treatment	Pain score record using a Numeric Rating Scale (NRS,0-10) , with 0 representing no pain and 10 representing the worst pain possible.	Subjects were assessed for the duration of study treatment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Health & Welfare, Korea
• Investigators: Principal Investigator: ChangSik Pak, Bachelor, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 15, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Skin Laxity; Rhytids
• Other Study ID Numbers: E-1411/274-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No