Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand|
- 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
- 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.
|Study Start Date:||February 2015|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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
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.
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 .
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02364440
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||ChangSik Pak, Bachelor||Seoul National University Bundang Hospital|