CompletedNCT03712137Updated Jan 4, 2023Results posted

Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

A Phase 3 interventional study of VOLUX XC and No-treatment control in Jawline Definition, sponsored by Allergan. Completed at 19 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 206
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study summary

This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition

Conditions studied

Jawline Definition

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.

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3
Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition
Written Informed Consent (IC) has been obtained

Exclusion criteria

Exclusion Criteria:

Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study
Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study
Has received deoxycholic acid treatment in the submental region in the last 6 months
Has active autoimmune disease
Females who are pregnant, nursing, or planning a pregnancy during the course of the study

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 206 participants (actual)

Study arms

Experimental
VOLUX XC
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.
Device: VOLUX XC
Experimental
No-treatment control
No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.
Other: No-treatment control

Interventions

DeviceVOLUX XC
Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with optional touch-up at day 30 and optional maintenance treatment at Month 12.
OtherNo-treatment control
No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) at the beginning of the Post-Control period.

What researchers measure

Primary outcomes

Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)
Time frame: Month 6

Secondary outcomes

Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.
Time frame: Month 6
Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.
Time frame: Month 6
Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score
The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best)
Time frame: Baseline to Month 6

Results

Posted Jan 4, 2023

Participant flow

Study consists of 2 groups: Treatment and Control. The treatment group rec'd treatment Day 1 and was followed up to Month 12. At Month 12 they had the option to exit the study or receive maintenance treatment with an add'l 3 months of follow-up after treatment. The control group followed a 6-month no-treatment control period after which they had the option to exit the study or proceed to the post-control period where they receive treatment with 12 months of follow-up after their last treatment.

Control Period

Participant flow — Control Period
Milestone	No-treatment Control	VOLUX XC
Started	49	157
Participants treated as randomized	49	156
Participants not treated as randomized	0	1
Completed	47	149
Not completed	2	8

Opt VOLUX Treatment Follow Up Period

Participant flow — Opt VOLUX Treatment Follow Up Period
Milestone	No-treatment Control	VOLUX XC
Started	42	0
Completed	35	0
Not completed	7	0

VOLUX Maintenance Treatment Period

Participant flow — VOLUX Maintenance Treatment Period
Milestone	No-treatment Control	VOLUX XC
Started	0	87
Completed	0	85
Not completed	0	2

Outcome measures

PrimaryPercentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)

The ALJDS is an Investigator assessment of loss of jawline definition measured by a 5-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme)

Time frame:: Month 6
Reported as:: Number · percentage of participants

Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)
percentage of participants	No-treatment Control	VOLUX XC
Percentage of Participants Who Show ≥ 1-point Jawline Improvement on Both Sides From Baseline on the Allergan Loss of Jawline Definition Scale (ALJDS)	38.0 (24.25 to 51.80)	69.0 (61.53 to 76.39)

Statistical analysis

VOLUX XC · Multiple Imputation · p = 0.0001 · Responder rate difference: 30.9 · 95% CI 15.33 to 46.54The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation

SecondaryPercentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)

The Evaluating Investigator (EI) will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.

Time frame:: Month 6
Reported as:: Count of participants · Participants

Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)
Participants	No-treatment Control	VOLUX XC
Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)	13	130

SecondaryPercentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)

The participant will assess the aesthetic improvement of the jawline area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.

Time frame:: Month 6
Reported as:: Count of participants · Participants

Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)
Participants	VOLUX XC
Percentage of Participants Who Note "Improved" or "Much Improved" in Jawline Area as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)	129

SecondaryChange From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score

The subject will assess satisfaction using the 5 questions on the Satisfaction of Lower Face and Jawline scale of the FACE-Q™ questionnaire measured on a 4-point scale (1=Very Dissatisfied 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied). The raw scale summed score will then be converted into a Rasch-transformed score from 0 (worst) to 100 (best)

Time frame:: Baseline to Month 6
Reported as:: Mean · score on a scale

Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score
score on a scale	VOLUX XC
Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score	45.9 ± 33.09

Statistical analysis

VOLUX XC · Paired T-test · p = <0.0001 · Mean difference (final values): 45.9 · 95% CI 40.45 to 51.28

Adverse events

Collected over 12 to 17 months for the treatment group and 6 to 20 months for the control group.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
No-treatment Control	0/50 (0%)	1/50 (2%)	0/50 (0%)
VOLUX XC Treatment	0/156 (0%)	17/156 (10.9%)	9/156 (5.8%)
Optional VOLUX XC Treatment Post Control	0/42 (0%)	3/42 (7.1%)	5/42 (11.9%)
VOLUX Maintenance Treatment	0/87 (0%)	4/87 (4.6%)	1/87 (1.1%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	No-treatment Control	VOLUX XC Treatment	Optional VOLUX XC Treatment Post Control	VOLUX Maintenance Treatment
INJECTION SITE NODULEGeneral disorders	0/50	0/156	1/42	2/87
BACTERIAL VAGINOSISInfections and infestations	0/50	0/156	1/42	0/87
COVID-19Infections and infestations	0/50	0/156	1/42	0/87
CLOSTRIDIUM DIFFICILE INFECTIONInfections and infestations	0/50	0/156	1/42	0/87
DIVERTICULITISInfections and infestations	1/50	0/156	1/42	0/87
SINUSITISInfections and infestations	0/50	3/156	0/42	0/87
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations	0/50	2/156	0/42	0/87
IMPLANT SITE INFECTIONInfections and infestations	0/50	0/156	0/42	1/87
URINARY TRACT INFECTIONInfections and infestations	0/50	1/156	0/42	1/87
BREAST NECROSISReproductive system and breast disorders	0/50	0/156	0/42	1/87

Most frequent other events

Most frequent other events
Event	No-treatment Control	VOLUX XC Treatment	Optional VOLUX XC Treatment Post Control	VOLUX Maintenance Treatment
SEASONAL ALLERGYImmune system disorders	0/50	2/156	3/42	0/87
HEADACHENervous system disorders	0/50	7/156	3/42	1/87

Baseline characteristics

Modified intent-to-treat (mITT) Population included all randomized participants with non-missing baseline on the ALJDS scale on both sides of the jaw

Age, Continuous
Age, Continuous(years)	No-treatment Control	VOLUX XC	Total
Mean	57.9 ± 9.37	59.3 ± 8.22	59.0 ± 8.50

Sex: Female, Male
Sex: Female, Male(Participants)	No-treatment Control	VOLUX XC	Total
Female	39	141	180
Male	10	16	26

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	No-treatment Control	VOLUX XC	Total
Hispanic or Latino	11	31	42
Not Hispanic or Latino	38	126	164
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	No-treatment Control	VOLUX XC	Total
American Indian or Alaska Native	0	1	1
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	6	21	27
White	42	132	174
More than one race	1	3	4
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	No-treatment Control	VOLUX XC	Total
United States	49	157	206

Participant Level Allergan Loss of Jawline Definition Scale (ALJDS)
Participant Level Allergan Loss of Jawline Definition Scale (ALJDS)(units on a scale)	No-treatment Control	VOLUX XC	Total
Moderate	13	34	47
Severe	36	114	150
Extreme	0	9	9

Study locations

19 sites

Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama 35205, United States
Westside Aesthetics
Los Angeles, California 90025, United States
Artemedica
Santa Rosa, California 95401, United States
Center for Dermatology and Dermatologic Surgery
Washington, District of Columbia 20037, United States
Susan H Weinkle, MD
Bradenton, Florida 34209, United States
Hevia Cosmetic Dermatology
Coral Gables, Florida 33134, United States
Skin Research Institute LLC
Coral Gables, Florida 33146, United States
Baumann Cosmetic and Research Institute
Miami, Florida 33137, United States
DeNova Research dba Arano, LLC
Chicago, Illinois 60611, United States
Callender Center for Clinical Research
Glenn Dale, Maryland 20769, United States
MDLSV
Hunt Valley, Maryland 21030, United States
Williams Center
Latham, New York 12110, United States
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York 10549, United States
Center aesthetic and dermatology
New York, New York 10003, United States
Laser & Skin Surgery Center of New York
New York, New York 10016, United States
Aesthetic Solutions, PA.
Chapel Hill, North Carolina 27517, United States
Bellaire Dermatology Associates
Bellaire, Texas 77401, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Houston, Texas 77056, United States
SkinDC
Arlington, Virginia 22209, United States

References and documents

Study documents

Study protocol · Mar 11, 2019
Statistical analysis plan · Apr 28, 2020

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03712137
Lead sponsor: Allergan
Responsible party: Sponsor
First posted: Oct 19, 2018
Start date: Nov 12, 2018
Primary completion: Feb 4, 2020
Completion: Jan 26, 2021
Results posted: Jan 4, 2023
Last update: Jan 4, 2023

Study contacts

Marta Sartor

study director · Allergan

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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