Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

May 7, 2015 updated by: Seoul National University Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultherapy™ System
Device: Ultherapy™ System
Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's evaluation of 5-point Hand grading scale
Time Frame: 12 weeks post-treatment
2 assessors will be evaluate 5-point Hand grading scale from baseline and 12weeks post treatment
12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks post-treatment
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.
Subjects were assessed for the duration of study treatment
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 post-treatment
12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: ChangSik Pak, Bachelor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-1405/250-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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