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NCT Number: NCT02368925

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

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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Key information

Conditions

Wrinkles Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultherapy™ System

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.

Primary outcomes

  1. 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

  1. Subject Assessment of Improvement at 12 weeks post-treatment

    Time frame: 12 weeks post-treatment

    Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks posttreatment

  2. Subjects' Assessment of Pain during treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 23, 2015
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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