Trial Outcomes & Findings for Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition (NCT NCT03712137)

Last Updated: 2023-01-04

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

206 participants

Primary outcome timeframe

Month 6

Results posted on

2023-01-04

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.

Participant milestones

Participant milestones
Measure	No-treatment Control No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	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. 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.
Control Period STARTED	49	157
Control Period Participants Treated as Randomized	49	156
Control Period Participants Not Treated as Randomized	0	1
Control Period COMPLETED	47	149
Control Period NOT COMPLETED	2	8
Opt VOLUX Treatment Follow Up Period STARTED	42	0
Opt VOLUX Treatment Follow Up Period COMPLETED	35	0
Opt VOLUX Treatment Follow Up Period NOT COMPLETED	7	0
VOLUX Maintenance Treatment Period STARTED	0	87
VOLUX Maintenance Treatment Period COMPLETED	0	85
VOLUX Maintenance Treatment Period NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No-treatment Control n=49 Participants No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	VOLUX XC n=157 Participants 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. 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.	Total n=206 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 9.37 • n=5 Participants	59.3 years STANDARD_DEVIATION 8.22 • n=7 Participants	59.0 years STANDARD_DEVIATION 8.50 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	141 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	126 Participants n=7 Participants	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	21 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	132 Participants n=7 Participants	174 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	49 participants n=5 Participants	157 participants n=7 Participants	206 participants n=5 Participants
Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Moderate	13 units on a scale n=5 Participants	34 units on a scale n=7 Participants	47 units on a scale n=5 Participants
Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Severe	36 units on a scale n=5 Participants	114 units on a scale n=7 Participants	150 units on a scale n=5 Participants
Participant Level Allergan Loss of Jawline Definition Scale (ALJDS) Extreme	0 units on a scale n=5 Participants	9 units on a scale n=7 Participants	9 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: All modified intent-to-treat (mITT) participants who have Month 6 assessment on the ALJDS scale on both sides of the jaw. Multiple imputation was performed on participants with missing data for the Month 6 assessment on the ALJDS on both sides of jaw

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)

Outcome measures

Outcome measures
Measure	No-treatment Control n=49 Participants No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	VOLUX XC n=157 Participants 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. 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.
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 percentage of participants Interval 24.25 to 51.8	69.0 percentage of participants Interval 61.53 to 76.39

SECONDARY outcome

Timeframe: Month 6

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

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.

Outcome measures

Outcome measures
Measure	No-treatment Control n=45 Participants No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	VOLUX XC n=146 Participants 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. 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.
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 Participants	130 Participants

SECONDARY outcome

Timeframe: Month 6

Population: As per the Protocol and the Statistical Analysis Plan: During the Control Period these data were collected only for participants that were randomized and received VOLUX treatment at the beginning of the Control Period

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.

Outcome measures

Outcome measures
Measure	No-treatment Control n=146 Participants No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	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. 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.
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 Participants	—

SECONDARY outcome

Timeframe: Baseline to Month 6

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)

Outcome measures

Outcome measures
Measure	No-treatment Control n=146 Participants No-treatment at the beginning of the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. No-treatment control: No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.	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. 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.
Change From Baseline in Overall Score for FACE-Q™ Satisfaction With Lower Face and Jawline Score	45.9 score on a scale Standard Deviation 33.09	—

Adverse Events

No-treatment Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

VOLUX XC Treatment

Serious events: 17 serious events

Other events: 9 other events

Deaths: 0 deaths

Optional VOLUX XC Treatment Post Control

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

VOLUX Maintenance Treatment

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	No-treatment Control n=50 participants at risk No-treatment during the control period. No-treatment control: No-treatment during the control period. (randomization to Month 6)	VOLUX XC Treatment n=156 participants at risk 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. 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.	Optional VOLUX XC Treatment Post Control n=42 participants at risk Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period (optional treatment to study exit).	VOLUX Maintenance Treatment n=87 participants at risk Participants in the VOLUX XC Treatment population who received VOLUX maintenance treatment at Month 12
Immune system disorders SEASONAL ALLERGY	0.00% 0/50 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	1.3% 2/156 • Number of events 2 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	7.1% 3/42 • Number of events 3 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	0.00% 0/87 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.
Nervous system disorders HEADACHE	0.00% 0/50 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	4.5% 7/156 • Number of events 7 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	7.1% 3/42 • Number of events 3 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.	1.1% 1/87 • Number of events 1 • 12 to 17 months for the treatment group and 6 to 20 months for the control group. All randomized participants who receive study treatment (VOLUX or control) make up the Safety Population. There is one participant, that was randomized in error, that did not receive the treatment and is assigned to the control treatment arm for reporting purposes.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER