Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands
This trial is active, not recruiting.
|Start date||October 2015|
|End date||April 2016|
|Trial size||109 participants|
|Trial identifier||NCT02545608, 43CH1406|
The purpose of this study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Restylane Vital in one of the hands
No treatment in the other hand.
The efficacy of Restylane Vital on skin structure compared to no treatment using a validated scale.
time frame: 12 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - Signed Informed Consent - Chinese origin - Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions Exclusion Criteria: - Any previous non-permanent implant/filler in the hands - Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline - Any previous hand surgery - Any fibrosis or scarring or deformities on the hands - Advanced photoaged/photodamaged skin
|Official title||A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects|
Call for more information