Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy Evaluation of Ultherapy™ System in Aging Hand

Conditions
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Wrinkles

Intervention / Treatment
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* Device: Ultherapy™ System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin laxity, Ultherapy™ System, rhytids