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

Galderma R&D109 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

109

Conditions

Dorsal Hands

Interventions

Restylane VitalDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Beijing, China

Unnamed facility

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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