Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands
Not Applicable
Completed
- Conditions
- Dorsal Hands
- Interventions
- Device: Restylane Vital
- Registration Number
- NCT02545608
- Lead Sponsor
- Galderma R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Restylane Vital and No treatment Restylane Vital Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand Restylane Vital in both hands Restylane Vital Open group used to develop a proper use of injection technique for Restylane Vital
- Primary Outcome Measures
Name Time Method The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. 12 weeks Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method