Study to Evaluate Satisfaction After Treatment With Restylane

Cheek Augmentation Clinical Trial

Official title:

A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638816
• Other study ID #: 05DF2004
• Status: Completed
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: August 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 20, 2021
• Est. primary completion date: July 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed and dated informed consent to participate in the study

• Adult women who intend to undergo cheek augmentation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cheek Augmentation

Intervention

Device:
• Restylane Volyme
Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
• Restylane Lyft Lidocaine
Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).

Locations

Country	Name	City	State
Canada	Galderma Study Site	Montreal	Quebec
Canada	Galderma Study Site	Vancouver	British Columbia
Canada	Galderma Study Site	Woodbridge	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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