NCT02650921
Completed
Not Applicable
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
ConditionsVolume Deficit in the Hand
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Volume Deficit in the Hand
- Sponsor
- Galderma R&D
- Enrollment
- 92
- Primary Endpoint
- Responder Rate Using Validated Hand Grading Scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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 .
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.
Outcomes
Primary Outcomes
Responder Rate Using Validated Hand Grading Scale
Time Frame: 12 Weeks
A responder is defined as a hand with at least one improvement from baseline.
Secondary Outcomes
- Question 12 From Subject Satisfaction Questionnaire(Week 12)
- Question 4 From Subject Satisfaction Questionnaire(Week 12)
- Question 3 From Subject Satisfaction Questionnaire(Week 12)
- Question 8 From Subject Satisfaction Questionnaire(Week 12)
- Question 11 From Subject Satisfaction Questionnaire(Week 12)
- Responder Rate Using Validated Hand Grading Scale(24 weeks)
- Improvement in Hand as Evaluated by IPR(24 weeks)
- GAIS by Treating Investigator(24 weeks)
- Evaluate GAIS by Subjects(20 weeks)
- Evaluate GAIS by Subject(24 weeks)
- Question 2 From Subject Satisfaction Questionnaire(Week 12)
- Question 7 From Subject Satisfaction Questionnaire(Week 12)
- Question 9 From Subject Satisfaction Questionnaire(Week 12)
- Question 10 From Subject Satisfaction Questionnaire(Week 12)
- Question 6 From Subject Satisfaction Questionnaire(Week 12)
- Question 1 From Subject Satisfaction Questionnaire(Week 12)
- Question 5 From Subject Satisfaction Questionnaire(Week 12)
- Question 13 From Subject Satisfaction Questionnaire(Week 12)
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