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OpenTrials
Completed

NCT Number: NCT02545608

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

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.

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Key information

Conditions

Dorsal Hands

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restylane Vital

Device

Primary outcomes

  1. The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 10, 2015
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.