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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
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Enrolled subjects will receive Ultherapyâ„¢ 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
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 Ultherapyâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultherapyâ„¢ System | Experimental | Ultherapyâ„¢ System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultherapyâ„¢ System | Device | Subjects will receive 20 lines Ultherapyâ„¢ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ChangSik Pak, Bachelor | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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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 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |