Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Seoul National University Hospital7 enrolled

Overview

Enrolled subjects will receive Ultherapy™ System treatment on the back of their both hands. Follow-up visits will occur at 90 days post-treatment. Study photos will be obtained pre-treatment and at 90 days post-treatment

Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the 5-point Hand Grading Scale wil be evaluated by the Investigator in charge of assessment. Treatment: The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 20 lines of 1.5 and 3.0 probe respectively to the back of the left and right hand . Post-Treatment: All subjects will visit the Institution at12 weeks from the day of procedure, and will take photos of the back of the hands. Efficacy evaluation will performed by the Photographic Evaluator.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Wrinkles

Interventions

Ultherapy™ SystemDEVICE

Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, aged 30 to 65 years. * Score of 1 to 3 on The 5-point Hand Grading Scale * Subjects who understand the study contents and signed the informed consent Exclusion Criteria: * Presence of an active systemic infectious disease * Significant scarring in the hand to be treated * Previous episode of surgery in the hand to be treated * Subjects who have aesthetic addiction, drug abuse, alcohol abuse

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Investigator's evaluation of 5-point Hand grading scale

2 assessors will be evaluate 5-point Hand grading scale from baseline and 12weeks post treatment

Time frame: 12 weeks post-treatment

Secondary Outcomes

Subject Assessment of Improvement at 12 weeks post-treatment

Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks post-treatment

Time frame: 12 weeks post-treatment

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

Time frame: 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.

Time frame: Subjects were assessed for the duration of study treatment

Data from ClinicalTrials.gov

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