Effectiveness and Safety of Restylane Lyft With Lidocaine in the Dorsal Hand
This trial has been completed.
|Condition||volume deficit in the hand|
|Treatment||restylane lyft with lidocaine|
|Start date||December 2015|
|End date||July 2016|
|Trial size||117 participants|
|Trial identifier||NCT02650921, 43USH1501|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Vista, CA||not available||completed|
|Boulder, CO||not available||completed|
|Englewood, CO||not available||completed|
|Boca Raton, FL||not available||completed|
|St. Louis, MO||not available||completed|
|Mt Kisco, NY||not available||completed|
|New York, NY||not available||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Change from Baseline using validated scale at 12 Weeks
time frame: 12 Weeks
Male or female participants at least 22 years old.
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.
|Official title||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|
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