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

July 10, 2020 updated by: Allergan

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
Time Frame: Baseline (up to 30 days prior to randomization) to Month 6
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
Time Frame: Baseline (up to 30 days prior to randomization) to Month 6
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
Time Frame: Baseline (up to 30 days prior to randomization) to Month 6
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
Time Frame: Baseline (up to 30 days prior to randomization) to Month 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrew Schumacher, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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