Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands

Not Applicable

Completed

• Conditions: Dorsal Hands

• 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

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Study Start: 2015-10
• Primary Completion: 2016-04
• Study Completion: 2017-03-15
• Disposition First Submitted: 2017-06-08
• Disposition First Submitted QC: 2017-06-08
• Disposition First Posted: 2017-06-12
• Results First Submitted: 2018-03-15
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-13
• Results First Posted: 2019-06-14
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

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

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.