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A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

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: NCT03438266
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using cannula in participants seeking correction of age-related volume deficit in the mid-face.

Condition or disease Intervention/treatment Phase
Age-related Volume Deficit in the Mid-face Device: JUVÉDERM VOLUMA® XC injectable gel with cannula Device: JUVÉDERM VOLUMA® XC injectable gel with needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula
Actual Study Start Date : February 5, 2018
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : August 2, 2018

Arm Intervention/treatment
Experimental: JUVÉDERM VOLUMA® XC Injectable Gel with Cannula
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
Device: JUVÉDERM VOLUMA® XC injectable gel with cannula
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.

JUVÉDERM VOLUMA® XC Injectable Gel with Needle
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Device: JUVÉDERM VOLUMA® XC injectable gel with needle
Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.




Primary Outcome Measures :
  1. Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score [ Time Frame: Baseline (Screening) to Month 1 ]
    The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.


Secondary Outcome Measures :
  1. Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score [ Time Frame: Baseline (Screening) to Month 1 ]
    The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.

  2. Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score [ Time Frame: Baseline (Screening) to Month 1 ]
    The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 3 months ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female aged 35 to 65 (inclusive) years of age with overall mid-face severity of Moderate, Significant, or Severe for both cheeks on the Mid-Face Volume Deficit Scale (MFVDS);

Exclusion criteria:

  • Has any facial procedures or trauma that may interfere with the study procedures and results;
  • Has a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo allergen desensitization therapy during the term of the study;
  • Has active autoimmune disease;
  • Has current cutaneous or mucosal inflammatory or infectious processes.

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): NCT03438266


Locations
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United States, California
Skin Care and Laser Physicians of Beverly Hills
Los Angeles, California, United States, 90069
Art of Skin MD
Solana Beach, California, United States, 92075
United States, Florida
Baumann Cosmetic and Research Institute
Miami, Florida, United States, 33137
United States, Missouri
Saint Louis University Dermatology
Saint Louis, Missouri, United States, 63122
United States, New Jersey
Skin Laser & Surgery Specialists of NY/NJ
Hackensack, New Jersey, United States, 07601
United States, New York
Rhoda S. Narins, MD, PC
White Plains, New York, United States, 10604
United States, North Carolina
Aesthetic Solutions, PA
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Steve Abrams Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] October 19, 2017
Statistical Analysis Plan  [PDF] July 13, 2018


Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03438266    
Other Study ID Numbers: 1650-801-008
First Posted: February 19, 2018    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: August 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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents