Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Wrinkles Clinical Trial

Official title:

Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364440
• Other study ID #: E-1405/250-001
• Status: Completed
• Phase: N/A
• First received: February 10, 2015
• Last updated: May 7, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: February 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks post-treatment	No
Secondary	Subject Assessment of Improvement at 12 weeks post-treatment	Subjects complete a Patient Assessment Global Aesthetic Improvement Scale at 12 weeks post-treatment	12 weeks post-treatment	No
Secondary	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	12 weeks post-treatment	No
Secondary	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.	Subjects were assessed for the duration of study treatment	Yes