Trial Outcomes & Findings for A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation (NCT NCT02833077)

Last Updated: 2020-07-23

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

221 participants

Primary outcome timeframe

Baseline (up to 30 days prior to randomization) to Month 6

Results posted on

2020-07-23

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 milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	144	48
Overall Study Participants Treated	144	38
Overall Study COMPLETED	127	40
Overall Study NOT COMPLETED	17	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	10	1
Overall Study Personal Reasons	6	4
Overall Study Protocol Deviation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JUVÉDERM VOLUMA® XC n=144 Participants 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 mL for both treatments combined.	No Treatment Then JUVÉDERM VOLUMA® XC n=48 Participants 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.	Total n=192 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 13.4 • n=5 Participants	48.9 years STANDARD_DEVIATION 14.3 • n=7 Participants	49.8 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	41 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	6 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=5 Participants	42 Participants n=7 Participants	159 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	116 Participants n=5 Participants	41 Participants n=7 Participants	157 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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 North America	144 Participants n=5 Participants	48 Participants n=7 Participants	192 Participants n=5 Participants

PRIMARY outcome

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

Population: The 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. Overall number of participants analyzed were the participants with analysis values at both Baseline and Post-baseline during the specified time period.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC n=126 Participants 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 mL for both treatments combined.	No Treatment Then JUVÉDERM VOLUMA® XC n=40 Participants 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.
Percentage of Participants With a ≥ 1-point Improvement (Decrease) on the Allergan Chin Retrusion Scale (ACSR) Score	56.3 percentage of participants	27.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC n=126 Participants 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 mL for both treatments combined.	No Treatment Then JUVÉDERM VOLUMA® XC n=40 Participants 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.
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire Baseline	35.7 score on a scale Standard Deviation 17.7	35.3 score on a scale Standard Deviation 14.9
Change From Baseline in Overall Scores of the Satisfaction With Chin Module of the FACE-Q Questionnaire Change from Baseline to Month 6	35.6 score on a scale Standard Deviation 23.2	-3.3 score on a scale Standard Deviation 11.5

SECONDARY outcome

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

Population: The 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. Overall number analyzed is the number of participants with data available for analyses.

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC n=125 Participants 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 mL for both treatments combined.	No Treatment Then JUVÉDERM VOLUMA® XC n=41 Participants 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.
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	91.2 percentage of participants	19.5 percentage of participants

SECONDARY outcome

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

Population: Participants in the mITT population who were randomized to the treatment group and received at least 1 study treatment with available data were included in the analyses.

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.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC n=126 Participants 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 mL for both treatments combined.	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.
Percentage of Participants Improved or Much Improved on the 5-Point GAIS for the Chin Area As Assessed by the Participants	87.3 percentage of participants	—

Adverse Events

JUVÉDERM VOLUMA® XC

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

JUVÉDERM VOLUMA® XC After No Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER