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

Not Applicable

Completed

• Conditions: Wrinkles
• Interventions: Device: Ultherapy™ System

• Registration Number: NCT02368925
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2015-02-15
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-23
• Study Start: 2015-03
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Male or female, aged 30 to 65 years.
• Subject in good health
• Subjects who desire improvement in neck skin

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultherapy™ System	Ultherapy™ System	Ultherapy™ System

Primary Outcome Measures

Name	Time	Method
Investigator Assessment of Improvement at 12 weeks post-treatment	12 weeks post-treatment	Investigator complete Global Aesthetic Improvement Scale at 12 weeks post-treatment by comparing subject's photographs

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do,, Korea, Republic of