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Study to Evaluate Satisfaction After Treatment With Restylane

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: NCT04638816
Recruitment Status : Completed
First Posted : November 20, 2020
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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Brief Summary:
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane

Condition or disease Intervention/treatment Phase
Cheek Augmentation Device: Restylane Volyme Device: Restylane Lyft Lidocaine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane
Actual Study Start Date : April 16, 2021
Actual Primary Completion Date : July 3, 2021
Actual Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Restylane Volyme
Hyaluronic Acid
 Device: Restylane Volyme
Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
Experimental: Restylane Lyft Lidocaine
Hyaluronic Acid
 Device: Restylane Lyft Lidocaine
Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).


Outcome Measures
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Primary Outcome Measures :
  1. Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS [ Time Frame: 4 weeks after last treatment ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female adult subject.
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT04638816


Locations
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Canada, British Columbia
Galderma Study Site
Vancouver, British Columbia, Canada
Canada, Ontario
Galderma Study Site
Woodbridge, Ontario, Canada
Canada, Quebec
Galderma Study Site
Montreal, Quebec, Canada
Sponsors and Collaborators
Q-Med AB
Investigators
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Study Director: Study Director Q-Med AB
More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT04638816    
Other Study ID Numbers: 05DF2004
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
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: No
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