A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

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

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.

Study Overview

• Status: Completed
• Conditions: Chin Retrusion
• Intervention / Treatment: Device: JUVÉDERM VOLUMA® XC

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute
    • Miami Beach, Florida, United States, 33137
      • Baumann Cosmetic and Res. Institute
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of the Southeast
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • Maryland
    • Glenn Dale, Maryland, United States, 20769
      • Callender Dermatology and Cosmetic Center
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 01467
      • Skincare Physicians of Chestnut Hill
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • St Louis University Medical Center Dept. of Dermatology
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Image Dermatology, PC
  • New York
    • Latham, New York, United States, 12110
      • Williams Plastic Surgery Specialists
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetics, & Laser Surgery
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Dermatology & Laser Center of Charleston Center for Clinical Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Centre for Laser and Facial Surgery
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research; Spokane Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Chin retrusion
• In good general health

Exclusion Criteria:

• Permanent facial implants on the face and/or neck
• Received fat injections below the nose
• Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
• Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
• Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
• Received dermal filler injections in the lips or in the mouth area in the last 12 months
• Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
• Received botulinum toxin treatment below the nose in the last 6 months

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; JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator on Day 0. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 milliliters (mL) for both treatments combined.	Device: JUVÉDERM VOLUMA® XC; JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.
Other: No Treatment then JUVÉDERM VOLUMA® XC; No treatment for 6 months followed by optional treatment with JUVÉDERM VOLUMA® XC injected into the chin at a volume determined by the investigator on Month 6. Participants were eligible to receive touch-up treatment 30 days later, if applicable. The maximum total volume administered was up to 4 mL for both treatments combined.	Device: JUVÉDERM VOLUMA® XC; JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score	The evaluating investigator assessed the participant's chin retrusion based on 2-dimensional (2D) renderings of 3-dimensional (3D) images using the validated 5-point photonumeric ACRS where: 0= None (no chin retrusion) to 4=Extreme (extreme chin retrusion).	Baseline (up to 30 days prior to randomization) to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire	The participant answered 10 question on the chin module of the FACE-Q about their satisfaction with their chin using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied and 4=Very Satisfied. The total score was transformed to a score of 0 (worse) to 100 (best). A positive change from Baseline indicates improvement.	Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS) for the Chin Area As Assessed by the Evaluating Investigator	The evaluating investigator assessed the participant's chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.	Baseline (up to 30 days prior to randomization) to Month 6
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants	The participants who received JUVÉDERM VOLUMA® XC, assessed their chin area using the GAIS where: 2=Much Improved, 1=Improved, 0=No change, -1=Worse and -2=Much Worse.	Baseline (up to 30 days prior to randomization) to Month 6

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Andrew Schumacher, Allergan

Publications and helpful links

General Publications

• Beer K, Kaufman-Janette J, Bank D, Biesman B, Dayan S, Kim W, Chawla S, Schumacher A. Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L. Dermatol Surg. 2021 Jan 1;47(1):80-85. doi: 10.1097/DSS.0000000000002795.

Helpful Links

• More Information

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Voluma-006

Drug and device information, study documents

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