Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Not Applicable

Completed

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

• Registration Number: NCT02364440
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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

Secondary 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
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 post-treatment
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