NCT04638816

Brief Summary

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

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

First Submitted

Initial submission to the registry

November 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 6, 2024

Completed
Last Updated

March 6, 2024

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

November 16, 2020

Results QC Date

August 24, 2022

Last Update Submit

August 11, 2023

Conditions

Cheek Augmentation

Outcome Measures

Primary Outcomes (1)

  • Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS

    The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.

    4 weeks after last treatment, up to 6 weeks

Study Arms (2)

Restylane Volyme

EXPERIMENTAL

Hyaluronic Acid

Device: Restylane Volyme

Restylane Lyft Lidocaine

EXPERIMENTAL

Hyaluronic Acid

Device: Restylane Lyft Lidocaine

Interventions

Restylane VolymeDEVICE

Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).

Restylane Volyme
Restylane Lyft LidocaineDEVICE

Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).

Restylane Lyft Lidocaine

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale adult subject.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated informed consent to participate in the study
  • Adult women who intend to undergo cheek augmentation

You may not qualify if:

  • Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
  • Subjects with a previous implant other than HA in or near the intended treatment site
  • Participation in any other clinical study within three (3) months before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Galderma Study Site

Vancouver, British Columbia, Canada

Location

Galderma Study Site

Woodbridge, Ontario, Canada

Location

Galderma Study Site

Montreal, Quebec, Canada

Location

Results Point of Contact

Title
Clinical Project Manager
Organization
QMedAB
aestheticclinicaltrials@galderma.com
(817) 961-500

Study Officials

  • Study Director

    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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 20, 2020

Study Start

April 16, 2021

Primary Completion

July 3, 2021

Study Completion

August 20, 2021

Last Updated

March 6, 2024

Results First Posted

March 6, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)