Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

Cheek Augmentation Clinical Trial

Official title:

A Multicenter, Open-Label, Prospective Study of Cannula Injection of Restylane Lyft With Lidocaine for Cheek Augmentation and the Correction of Age Related Midface Contour Deficiencies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160716
• Other study ID #: 43USC1633
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: May 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Primary Inclusion Criteria:

• Subjects willing to comply with the requirements of the study and providing a signed written informed consent.

• Males or non-pregnant, non-breastfeeding females, 22 years of age or older.

• Mild to Substantial Midface Volume Loss

Primary Exclusion Criteria:

• Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins

• Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents

• Undergone prior surgery to midface

Related Conditions & MeSH terms

• Cheek Augmentation
• Midface Contour Deficiencies

Intervention

Device:
• Restylane Lyft with Lidocaine
a sterile gel of hyaluronic acid (HA)

Locations

Country	Name	City	State
United States	Facial Plastic and Cosmetic Surgery	Beverly Hills	California
United States	Skin Care and Laser Physicians of Beverly Hills	Los Angeles	California
United States	Union Square Laser Dermatology	New York	New York
United States	Hessler Plastic Surgery	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events [Safety]	To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.	16 weeks
Secondary	Number of Participants With Aesthetic Improvement	To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).	16 weeks
Secondary	Number of Participants That Responded to Treatment	To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).	16 weeks
Secondary	Subject Satisfaction	To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.	8 weeks