Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
Status
Completed
Conditions
Volume Deficit in the Hand
Treatments
Device: Restylane Lyft with Lidocaine
Details and patient eligibility
About
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.
Enrollment
92 patients
Sex
All
Ages
22+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
92 participants in 2 patient groups
Restylane Lyft with Lidocaine
Experimental group
Treatment:
Device: Restylane Lyft with Lidocaine
No Intervention
No Intervention group
Trial contacts and locations
7
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Data sourced from clinicaltrials.gov
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