N/A N=109 Randomized Single-blind Treatment

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

Dorsal Hands

Bottom Line

View on ClinicalTrials.gov: NCT02545608 ↗

Enrolled (actual)

109

Serious AEs

1.9%

Results posted

Jun 2019

Primary outcome: Primary: The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale. — 0.85; 2.17 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane Vital (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.	0.85; 2.17	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02545608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.