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Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03160716
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : May 15, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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.

Condition or disease Intervention/treatment Phase
Cheek Augmentation Midface Contour Deficiencies Device: Restylane Lyft with Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Treatment Device: Restylane Lyft with Lidocaine
a sterile gel of hyaluronic acid (HA)




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events [Safety] [ Time Frame: 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 :
  1. Number of Participants With Aesthetic Improvement [ Time Frame: 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).

  2. Number of Participants That Responded to Treatment [ Time Frame: 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).

  3. Subject Satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160716


Locations
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United States, California
Facial Plastic and Cosmetic Surgery
Beverly Hills, California, United States, 90210
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Hessler Plastic Surgery
Palo Alto, California, United States, 94306
United States, New York
Union Square Laser Dermatology
New York, New York, United States, 10003
Sponsors and Collaborators
Q-Med AB
  Study Documents (Full-Text)

Documents provided by Q-Med AB:
Study Protocol  [PDF] April 10, 2017
Statistical Analysis Plan  [PDF] May 9, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03160716    
Other Study ID Numbers: 43USC1633
First Posted: May 19, 2017    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Lidocaine
Hyaluronic Acid
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents