NCT03869450

Brief Summary

The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
3 countries

3 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

Study Start

First participant enrolled

November 9, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 2, 2020

Completed
Last Updated

August 26, 2022

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

November 14, 2018

Results QC Date

March 17, 2020

Last Update Submit

August 24, 2022

Conditions

Volume Deficiency of the Midface

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Aesthetic Improvement of Midface

    A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.

    8 weeks

Secondary Outcomes (2)

  • Percentage of Participants With Improved Midface Volume

    8 weeks

  • Percentage of Participants Assessed as Having Natural Treatment Results

    8 weeks

Study Arms (3)

Restylane Volyme

EXPERIMENTAL

According to the treatment algorithm, treated with Restylane Volyme

Device: Restylane Volyme

Restylane Defyne

EXPERIMENTAL

According to the treatment algorithm, treated with Restylane Defyne

Device: Restylane Defyne

Restylane Lyft Lidocaine

EXPERIMENTAL

According to the treatment algorithm, treated with Restylane Lyft Lidocaine

Device: Restylane Lyft Lidocaine

Interventions

Restylane VolymeDEVICE

Hyaluronic based filler

Restylane Volyme
Restylane DefyneDEVICE

Hyaluronic based filler

Restylane Defyne
Restylane Lyft LidocaineDEVICE

Hyaluronic based filler

Restylane Lyft Lidocaine

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
  • Signed and dated informed consent

You may not qualify if:

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
  • Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
  • Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Galderma Research Site

Munich, 80636, Germany

Location

Galderma Research Site

Palermo, 90141, Italy

Location

Galderma Research Site

Edinburgh, EH10 4BE, United Kingdom

Location

Results Point of Contact

Title
Clinical Project Manager
Organization
Q-Med AB
reception.seupp@galderma.com
+4618 474 9000

Study Officials

  • Q-Med AB

    Galderma R&D

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

November 14, 2018

First Posted

March 11, 2019

Study Start

November 9, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

August 26, 2022

Results First Posted

April 2, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(1)IT(1)