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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultherapy™ System

Group Type EXPERIMENTAL

Ultherapy™ System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes