Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation
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
1 other identifier
interventional
60
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
May 15, 2019
CompletedAugust 26, 2022
May 1, 2019
6 months
May 14, 2017
April 25, 2019
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Number of Participants With Aesthetic Improvement
16 weeks
Number of Participants That Responded to Treatment
16 weeks
Subject Satisfaction
8 weeks
Study Arms (1)
Treatment
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (4)
Facial Plastic and Cosmetic Surgery
Beverly Hills, California, 90210, United States
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, 90069, United States
Hessler Plastic Surgery
Palo Alto, California, 94306, United States
Union Square Laser Dermatology
New York, New York, 10003, United States
Related Publications (1)
Jones DH, Hessler J, Chapas A, Jonas B, Crider J, Chopra R. Microcannula Injection of Large Gel Particle Hyaluronic Acid for Cheek Augmentation and the Correction of Age-Related Midface Contour Deficiencies. Dermatol Surg. 2020 Apr;46(4):465-472. doi: 10.1097/DSS.0000000000002105.
PMID: 31490308DERIVED
Results Point of Contact
- Title
- Reception
- Organization
- Q-Med AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2017
First Posted
May 19, 2017
Study Start
May 16, 2017
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
August 26, 2022
Results First Posted
May 15, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share