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

Galderma

Status: Completed

Conditions: Dorsal Hands

Treatments: Device: Restylane Vital

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545608

43CH1406

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Restylane Vital in both hands

Experimental group

Description:

Open group used to develop a proper use of injection technique for Restylane Vital

Treatment:

Device: Restylane Vital

Restylane Vital and No treatment

Other group

Description:

Split-hand design: Restylane Vital in one hand and initially no treatment in the other hand

Treatment:

Device: Restylane Vital