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

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

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.

Study Overview

• Status: Completed
• Conditions: Dorsal Hands
• Intervention / Treatment: Device: Restylane Vital

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Shanghai, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restylane Vital in both hands; Open group used to develop a proper use of injection technique for Restylane Vital	Device: Restylane Vital
Other: Restylane Vital and No treatment; Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand	Device: Restylane Vital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.	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.	12 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: August 21, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 43CH1406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No