Trial Outcomes & Findings for A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula (NCT NCT03438266)

Results Overview

The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Baseline (Screening) to Month 1

Results posted on

2019-08-05

Participant Flow

A total of 66 participants were enrolled in the study and 6 were excluded as screen failures. Only 60 participants were randomized and received study treatment.

Participant milestones

Participant milestones
Measure	JUVÉDERM VOLUMA® XC (All Participants) Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JUVÉDERM VOLUMA® XC (All Participants) n=120 Cheeks Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Age, Continuous	54.9 years STANDARD_DEVIATION 6.41 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race/Ethnicity, Customized White	59 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Screening) to Month 1

Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.

The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC Injectable Gel With Cannula n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.	JUVÉDERM VOLUMA® XC Injectable Gel With Needle n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score Baseline	3.5 score on a scale Standard Deviation 0.62	3.5 score on a scale Standard Deviation 0.62
Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score Change from Baseline at Month 1	-1.8 score on a scale Standard Deviation 1.03	-1.9 score on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline (Screening) to Month 1

Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.

The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) \[best\] to 5=Severe (wasting) \[worst\]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC Injectable Gel With Cannula n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.	JUVÉDERM VOLUMA® XC Injectable Gel With Needle n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score	93.3 percentage of participants Interval 83.8 to 98.15	95.0 percentage of participants Interval 86.08 to 98.96

SECONDARY outcome

Timeframe: Baseline (Screening) to Month 1

Population: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. FACE-Q is a global assessment and was administered per participant.

The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC Injectable Gel With Cannula n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.	JUVÉDERM VOLUMA® XC Injectable Gel With Needle Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score Baseline	32.1 score on a scale Standard Deviation 15.62	—
Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score Change from Baseline at Month 1	55.5 score on a scale Standard Deviation 25.06	—

SECONDARY outcome

Timeframe: Up to 3 months

Population: Safety population included all randomized participants who received at least 1 study treatment. The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.

Outcome measures

Outcome measures
Measure	JUVÉDERM VOLUMA® XC Injectable Gel With Cannula n=60 Participants Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.	JUVÉDERM VOLUMA® XC Injectable Gel With Needle Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	7 Participants	—

Adverse Events

JUVÉDERM VOLUMA® XC (All Participants)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	JUVÉDERM VOLUMA® XC (All Participants) n=60 participants at risk Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula and 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
Nervous system disorders Headache	5.0% 3/60 • Up to 3 months The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.

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