Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
- Conditions
- Volume Deficit in the Hand
- Interventions
- Device: Restylane Lyft with Lidocaine
- Registration Number
- NCT02650921
- Lead Sponsor
- Galderma R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restylane Lyft with Lidocaine Restylane Lyft with Lidocaine -
- Primary Outcome Measures
Name Time Method Responder Rate Using Validated Hand Grading Scale 12 Weeks A responder is defined as a hand with at least one improvement from baseline.
- Secondary Outcome Measures
Name Time Method Question 12 From Subject Satisfaction Questionnaire Week 12 Question 12: I would recommend this treatment to a friend
Question 4 From Subject Satisfaction Questionnaire Week 12 Question 4: My treated hand feels softer than my untreated hand
Question 3 From Subject Satisfaction Questionnaire Week 12 Question 3: My treated hand looks more youthful than my untreated hand
Question 8 From Subject Satisfaction Questionnaire Week 12 Question 8: My treated hand appears at least 5 years younger than my untreated hand
Question 11 From Subject Satisfaction Questionnaire Week 12 Question 11: The treatment result looks natural
Responder Rate Using Validated Hand Grading Scale 24 weeks A responder is defined as a hand with at least one point improvement from baseline.
Improvement in Hand as Evaluated by IPR 24 weeks Independent Photographic Reviewer's assessment of improvement (Yes/No)
GAIS by Treating Investigator 24 weeks Global Aesthetic Improvement Scale
Evaluate GAIS by Subjects 20 weeks Global Aesthetic Improvement Scale
Evaluate GAIS by Subject 24 weeks Global Aesthetic Improvement Scale
Question 2 From Subject Satisfaction Questionnaire Week 12 Question 2: My treated hand appears more attractive than my untreated hand
Question 7 From Subject Satisfaction Questionnaire Week 12 Question 7: The veins on my treated hand are less apparent compared to my untreated hand
Question 9 From Subject Satisfaction Questionnaire Week 12 Question 9: My treated hand appears at least 10 years younger than my untreated hand
Question 10 From Subject Satisfaction Questionnaire Week 12 Question 10: The skin on my treated hand appears hydrated
Question 6 From Subject Satisfaction Questionnaire Week 12 Question 6: My treated hand looks less bony than my untreated hand
Question 1 From Subject Satisfaction Questionnaire Week 12 Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand
Question 5 From Subject Satisfaction Questionnaire Week 12 Question 5: The skin on my treated hand appears tighter than on my untreated hand
Question 13 From Subject Satisfaction Questionnaire Week 12 Question 13: I would have another treatment to maintain these results