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CompletedNCT02833077Updated Jul 23, 2020Results posted

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

An interventional study of JUVÉDERM VOLUMA® XC in Chin Retrusion, sponsored by Allergan. Completed at 14 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Allergan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
221
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Chin Retrusion
03

In context

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chin retrusion
  • In good general health

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
221 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceJUVÉDERM 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

Secondary outcomes

  1. 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.

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

  2. 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.

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

  3. 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.

    Time frame: Baseline (up to 30 days prior to randomization) to Month 6

07

Results

Posted Jul 23, 2020

Participant flow

A total of 221 participants were enrolled in the study, with enrollment defined as signing the informed consent form. A total of 29 enrolled participants were screen failures (did not meet eligibility criteria). Thus, a total of 192 participants were randomized.

Participant flow — Overall Study
MilestoneJUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XC
Started14448
Participants treated14438
Completed12740
Not completed178
Withdrew: Adverse event12
Withdrew: Lost to follow-up101
Withdrew: Personal reasons64
Withdrew: Protocol deviation01

Outcome measures

PrimaryPercentage 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).

Time frame:
Baseline (up to 30 days prior to randomization) to Month 6
Reported as:
Number · percentage of participants
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score
percentage of participantsJUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XC
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score56.327.5
Statistical analysis
  • JUVÉDERM VOLUMA® XC vs No Treatment Then JUVÉDERM VOLUMA® XC · Fisher's exact test · p = 0.0019 (If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.) · Responder rate difference: 28.85 · 95% CI 11.16 to 45.60
SecondaryChange 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.

Time frame:
Baseline (up to 30 days prior to randomization) to Month 6
Reported as:
Mean · score on a scale
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire
score on a scaleJUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XC
Baseline35.7 ± 17.735.3 ± 14.9
Change from Baseline to Month 635.6 ± 23.2-3.3 ± 11.5
Statistical analysis
  • JUVÉDERM VOLUMA® XC · Two sided paired t-test · p = <.0001 (P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.)
SecondaryPercentage 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.

Time frame:
Baseline (up to 30 days prior to randomization) to Month 6
Reported as:
Number · percentage of participants
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
percentage of participantsJUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XC
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 Investigator91.219.5
SecondaryPercentage 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.

Time frame:
Baseline (up to 30 days prior to randomization) to Month 6
Reported as:
Number · percentage of participants
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants
percentage of participantsJUVÉDERM VOLUMA® XC
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants87.3

Adverse events

Collected over JUVÉDERM VOLUMA® XC: Up to 12 months following treatment. No Treatment then JUVÉDERM VOLUMA® XC: Up to 6 months during No Treatment; Up to 6 months following treatment (Up to Month 12). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
JUVÉDERM VOLUMA® XC0/144 (0%)10/144 (6.9%)0/144 (0%)
No Treatment0/48 (0%)4/48 (8.3%)0/48 (0%)
JUVÉDERM VOLUMA® XC After No Treatment0/38 (0%)1/38 (2.6%)0/38 (0%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventJUVÉDERM VOLUMA® XCNo TreatmentJUVÉDERM VOLUMA® XC After No Treatment
CholecystitisHepatobiliary disorders0/1440/481/38
PneumoniaInfections and infestations1/1441/480/38
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1441/480/38
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1441/480/38
Breast cancer stage IVNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1441/480/38
Non-cardiac chest painGeneral disorders1/1440/480/38
AppendicitisInfections and infestations1/1440/480/38
Uterine haemorrhageReproductive system and breast disorders1/1440/480/38
Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1440/480/38
Injection site cellulitisInfections and infestations1/1440/480/38

Baseline characteristics

Modified Intent-to-Treat (mITT) Population included all participants randomized to the treatment group who received at least 1 study treatment or all participants randomized to the control group.

Age, Continuous
Age, Continuous(years)JUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XCTotal
Mean50.1 ± 13.448.9 ± 14.349.8 ± 13.6
Sex: Female, Male
Sex: Female, Male(Participants)JUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XCTotal
Female12941170
Male15722
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)JUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XCTotal
Hispanic or Latino27633
Not Hispanic or Latino11742159
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)JUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XCTotal
American Indian or Alaska Native303
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American23629
White11641157
More than one race112
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)JUVÉDERM VOLUMA® XCNo Treatment Then JUVÉDERM VOLUMA® XCTotal
North America14448192
08

Study locations

14 sites
  • Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
    San Diego, California 92121, United States
  • Skin Research Institute
    Coral Gables, Florida 33146, United States
  • Baumann Cosmetic and Res. Institute
    Miami Beach, Florida 33137, United States
  • Research Institute of the Southeast
    West Palm Beach, Florida 33401, United States
  • DeNova Research
    Chicago, Illinois 60611, United States
  • Callender Dermatology and Cosmetic Center
    Glenn Dale, Maryland 20769, United States
  • SkinCare Physicians of Chestnut Hill
    Chestnut Hill, Massachusetts 01467, United States
  • St Louis University Medical Center Dept. of Dermatology
    Saint Louis, Missouri 63104, United States
  • Image Dermatology, PC
    Montclair, New Jersey 07042, United States
  • Williams Plastic Surgery Specialists
    Latham, New York 12110, United States
  • The Center for Dermatology, Cosmetics, & Laser Surgery
    Mount Kisco, New York 10549, United States
  • Dermatology & Laser Center of Charleston Center for Clinical Research
    Charleston, South Carolina 29414, United States
  • Nashville Centre for Laser and Facial Surgery
    Nashville, Tennessee 37203, United States
  • Premier Clinical Research; Spokane Dermatology Clinic
    Spokane, Washington 99202, United States
09

References and documents

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. PubMed 33347003 ↗

Study documents

  • Statistical analysis plan · Feb 28, 2017
  • Study protocol · Mar 1, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02833077
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Jul 14, 2016
Start date
Jun 28, 2016
Primary completion
Feb 6, 2018
Completion
Oct 11, 2018
Results posted
Jul 23, 2020
Last update
Jul 23, 2020

Study contacts

Andrew Schumacher
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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