Wrinkles
Conditions
Keywords
skin laxity, Ultherapy™ System, rhytids
Brief 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
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.
Interventions
DEVICEUltherapy™ System
Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively
Sponsors
Ministry of Health & Welfare, Korea
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's evaluation of 5-point Hand grading scale | 12 weeks post-treatment | 2 assessors will be evaluate 5-point Hand grading scale from baseline and 12weeks post treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Assessment of Improvement at 12 weeks post-treatment | 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 | 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 | 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. |
Countries
South Korea
Outcome results
None listed