A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.

Official Title
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A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss

Conditions
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Dorsal Hand Volume Loss

Intervention / Treatment
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* Device: YVOIRE Y-Solution 360


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 Years and older Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands Participants who are willing to undergo the treatment of dorsal hand to correct volume loss Exclusion Criteria: Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands Active inflammation or infection on the dorsal hands Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization) Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization) Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization) Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization) Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)

Ages Eligible for Study
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Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YVOIRE Y-Solution 360<br>Maximum 5 ml including touch-up | Device: YVOIRE Y-Solution 360<br>* Hyaluronic acid<br>|
| No Intervention: No-treatment<br>No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | Up to 52 weeks after treatment | 
| ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject | 5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) | Up to 52 weeks after treatment | 
| Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | 5-grade photonumeric hand grading scale (grade 0 - grade 4) | Up to 52 weeks after treatment | 
| Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject | 5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) | Up to 52 weeks after treatment | 
| Safety profile as assessed by incidence of adverse events |  | Up to 52 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyalunic acid, Filler, Dorsal hand, Medical device