Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

Not Applicable

Completed

• Conditions: Cheek Augmentation; Midface Contour Deficiencies
• Interventions: Device: Restylane Lyft with Lidocaine

• Registration Number: NCT03160716
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-14
• Study Start: 2017-05-16
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Results First Submitted: 2019-04-25
• Results First Submitted QC: 2019-04-25
• Status Verified: 2019-05
• Results First Posted: 2019-05-15
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Restylane Lyft with Lidocaine	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events [Safety]	16 weeks	To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Aesthetic Improvement	16 weeks	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).
Number of Participants That Responded to Treatment	16 weeks	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).
Subject Satisfaction	8 weeks	To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.

Trial Locations

Locations (4)

Union Square Laser Dermatology; 🇺🇸 New York, New York, United States

Skin Care and Laser Physicians of Beverly Hills; 🇺🇸 Los Angeles, California, United States

Facial Plastic and Cosmetic Surgery; 🇺🇸 Beverly Hills, California, United States

Hessler Plastic Surgery; 🇺🇸 Palo Alto, California, United States