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

A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

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.

Study Overview

• Status: Completed
• Conditions: Age-related Volume Deficit in the Mid-face
• Intervention / Treatment: Device: JUVÉDERM VOLUMA® XC injectable gel with cannula; Device: JUVÉDERM VOLUMA® XC injectable gel with needle

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills
    • Solana Beach, California, United States, 92075
      • Art of Skin MD
  • Florida
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University Dermatology
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser & Surgery Specialists of NY/NJ
  • New York
    • White Plains, New York, United States, 10604
      • Rhoda S. Narins, MD, PC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Aesthetic Solutions, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score	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.	Baseline (Screening) to Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score	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.	Baseline (Screening) to Month 1
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score	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.	Baseline (Screening) to Month 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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.	Up to 3 months

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 1650-801-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes