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

NCT ID: NCT02545608

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Dorsal Hands

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Restylane Vital in both hands

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

Group Type EXPERIMENTAL

Restylane Vital

Intervention Type DEVICE

Restylane Vital and No treatment

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

Group Type OTHER

Restylane Vital

Intervention Type DEVICE

Interventions

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Restylane Vital

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Q-Med AB

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Beijing, , China

Site Status

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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43CH1406

Identifier Type: -

Identifier Source: org_study_id

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