NCT02545608

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 14, 2019

Completed
Last Updated

August 26, 2022

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

August 21, 2015

Results QC Date

March 15, 2018

Last Update Submit

August 24, 2022

Conditions

Dorsal Hands

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

Restylane Vital in both hands

EXPERIMENTAL

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

Device: Restylane Vital

Restylane Vital and No treatment

OTHER

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

Device: Restylane Vital

Interventions

Restylane VitalDEVICE
Restylane Vital and No treatmentRestylane Vital in both hands

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Beijing, China

Location

Unknown Facility

Shanghai, China

Location

Results Point of Contact

Title
Head of Development
Organization
Q-Med AB
reception.seupp@galderma.com
+ 46 (0) 18 474 90 00

Study Officials

  • Q-Med AB

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 10, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

March 15, 2017

Last Updated

August 26, 2022

Results First Posted

June 14, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)