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Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02364440
First Posted: February 18, 2015
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
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

Condition Intervention
Wrinkles Device: Ultherapy™ System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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.


Enrollment: 7
Study Start Date: February 2015
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultherapy™ System
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364440


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Investigators
Principal Investigator: ChangSik Pak, Bachelor Seoul National University Bundang Hospital
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02364440     History of Changes
Other Study ID Numbers: E-1405/250-001
First Submitted: February 10, 2015
First Posted: February 18, 2015
Last Update Posted: May 8, 2015
Last Verified: February 2015

Keywords provided by Seoul National University Hospital:
skin laxity
Ultherapy™ System
rhytids