Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand

Study Overview
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Brief Summary
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This is a randomized, evaluator-blind, split hand, multi-center study of the effectiveness and safety or Restylane Lyft with Lidocaine compared to no treatment for injection in the dorsal hand to correct volume deficits.

Official Title
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A Randomized, Evaluator Blinded, Split-hand Study to Evaluate the Effectiveness and Safety of Restylane Lyft With Lidocaine Compared to no Treatment for Injection in the Dorsal Hand to Correct Volume Deficit

Conditions
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Volume Deficit in the Hand

Intervention / Treatment
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* Device: Restylane Lyft with Lidocaine


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing a signed written informed consent including release of copyright of hand images. Males or females, 22 years of age or older Willing and able to perform hand functionality tests . Key Exclusion Criteria: History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins. History of allergy or hypersensitivity to lidocaine or other amide type anesthetics. Previous hand surgery including sclerotherapy, or history of hand trauma. Advanced photo aged/ photo damaged skin or skin condition with very crinkled or fragile skin on the dorsal hands.

Ages Eligible for Study
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Minimum Age: 22 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: Restylane Lyft with Lidocaine<br> | Device: Restylane Lyft with Lidocaine<br>* An injectable gel of Hyaluronic Acid and Lidocaine<br>|
| No Intervention: No Intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one improvement from baseline. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline | 16 weeks | 
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline | 20 weeks | 
| Responder Rate Using Validated Hand Grading Scale | A responder is defined as a hand with at least one point improvement from baseline. | 24 weeks | 
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 12 weeks | 
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 16 weeks | 
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 20 weeks | 
| Improvement in Hand as Evaluated by IPR | Independent Photographic Reviewer's assessment of improvement (Yes/No) | 24 weeks | 
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 12 weeks | 
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 16 weeks | 
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 20 weeks | 
| GAIS by Treating Investigator | Global Aesthetic Improvement Scale | 24 weeks | 
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 12 weeks | 
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 16 weeks | 
| Evaluate GAIS by Subjects | Global Aesthetic Improvement Scale | 20 weeks | 
| Evaluate GAIS by Subject | Global Aesthetic Improvement Scale | 24 weeks | 
| Question 1 From Subject Satisfaction Questionnaire | Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand | Week 12 | 
| Question 2 From Subject Satisfaction Questionnaire | Question 2: My treated hand appears more attractive than my untreated hand | Week 12 | 
| Question 3 From Subject Satisfaction Questionnaire | Question 3: My treated hand looks more youthful than my untreated hand | Week 12 | 
| Question 4 From Subject Satisfaction Questionnaire | Question 4: My treated hand feels softer than my untreated hand | Week 12 | 
| Question 5 From Subject Satisfaction Questionnaire | Question 5: The skin on my treated hand appears tighter than on my untreated hand | Week 12 | 
| Question 6 From Subject Satisfaction Questionnaire | Question 6: My treated hand looks less bony than my untreated hand | Week 12 | 
| Question 7 From Subject Satisfaction Questionnaire | Question 7: The veins on my treated hand are less apparent compared to my untreated hand | Week 12 | 
| Question 8 From Subject Satisfaction Questionnaire | Question 8: My treated hand appears at least 5 years younger than my untreated hand | Week 12 | 
| Question 9 From Subject Satisfaction Questionnaire | Question 9: My treated hand appears at least 10 years younger than my untreated hand | Week 12 | 
| Question 10 From Subject Satisfaction Questionnaire | Question 10: The skin on my treated hand appears hydrated | Week 12 | 
| Question 11 From Subject Satisfaction Questionnaire | Question 11: The treatment result looks natural | Week 12 | 
| Question 12 From Subject Satisfaction Questionnaire | Question 12: I would recommend this treatment to a friend | Week 12 | 
| Question 13 From Subject Satisfaction Questionnaire | Question 13: I would have another treatment to maintain these results | Week 12 |