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

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368925
• Other study ID #: E-1411/274-002
• Status: Completed
• Phase: N/A
• First received: February 15, 2015
• Last updated: April 14, 2016
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do,

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes