Trial Outcomes & Findings for A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds (NCT NCT01976663)

NCT ID: NCT01976663

Last Updated: 2019-05-10

Results Overview

Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.

Recruitment status

COMPLETED

Study phase

Target enrollment

126 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2019-05-10

Participant Flow

126 subjects were enrolled (Enrolled Population); 123 subjects were randomized and treated (Modified Intent-to-Treat). Each subject had one nasolabial fold treated with JUVEDERM VOLIFT® XC and one treated with control. After initial treatment, subjects were eligible for touch-up, asymmetry correction, and repeat treatment per protocol.

Participant milestones

Participant milestones
Measure	JUVEDERM VOLIFT® XC Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
Overall Study STARTED	126
Overall Study Received Touch-up Treatment	63
Overall Study Received Asymmetry Correction	45
Overall Study Received Repeat Treatment	85
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	JUVEDERM VOLIFT® XC Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
Overall Study Completed 18 mos but no repeat treatment	24
Overall Study Personal Reasons	6
Overall Study Withdrawal by Subject	4
Overall Study Screen Failure	3
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

A Safety and Effectiveness Study of JUVÉDERM VOLIFT® XC Versus Control for Moderate to Severe Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JUVEDERM VOLIFT® XC n=123 Participants Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
Age, Customized 30 to 50 years	36 Participants n=5 Participants
Age, Customized 51 to 65 years	72 Participants n=5 Participants
Age, Customized >65 years	15 Participants n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: modified intent-to-treat (mITT): all randomized and treated subjects

Outcome measures

Outcome measures
Measure	JUVEDERM VOLIFT® XC n=123 Participants Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Control n=123 Participants Nasolabial folds treated with Control.
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) Baseline	2.6 Scores on a Scale Standard Deviation 0.49	2.6 Scores on a Scale Standard Deviation 0.49
Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) Month 6 (N=117, 117)	1.4 Scores on a Scale Standard Deviation 0.67	1.3 Scores on a Scale Standard Deviation 0.72

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure

Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None \[no wrinkle\] to 4=Extreme \[very deep wrinkle, redundant fold\]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.

Outcome measures

Outcome measures
Measure	JUVEDERM VOLIFT® XC n=117 Participants Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Control n=117 Participants Nasolabial folds treated with Control.
Percentage of Nasolabial Folds With ≥1-Point Improvement	93.2 Percentage of Nasolabial Folds 95% Confidence Interval 0.49 • Interval 87.0 to 97.0	86.3 Percentage of Nasolabial Folds Interval 78.7 to 92.0

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure

Outcome measures

Outcome measures
Measure	JUVEDERM VOLIFT® XC n=113 Participants Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Control n=113 Participants Nasolabial folds treated with Control.
Percentage of Nasolabial Folds With ≥1-Point Improvement	57.5 Percentage of Nasolabial Folds 95% Confidence Interval 0.49 • Interval 47.9 to 66.8	56.6 Percentage of Nasolabial Folds Interval 47.0 to 65.9

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point

Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.

Outcome measures

Outcome measures
Measure	JUVEDERM VOLIFT® XC n=123 Participants Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Control n=123 Participants Nasolabial folds treated with Control.
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score Baseline	32.1 Scores on a Scale Standard Deviation 14.70	32.0 Scores on a Scale Standard Deviation 14.94
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score Month 12 (N=112, 111)	25.8 Scores on a Scale Standard Deviation 23.08	23.4 Scores on a Scale Standard Deviation 22.83

Adverse Events

JUVEDERM VOLIFT® XC During Initial/Touch Up

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Control During Initial/Touch Up Treatment Period

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Not at NLF During Initial/Touch Up Treatment Period

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	JUVEDERM VOLIFT® XC During Initial/Touch Up n=123 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.	Control During Initial/Touch Up Treatment Period n=123 participants at risk Nasolabial folds treated with Control during the Initial/Touch Up period.	Not at NLF During Initial/Touch Up Treatment Period n=123 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.	JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment n=93 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
Cardiac disorders Cardiac Arrest	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Infections and infestations Diverticulitis	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Infections and infestations Pneumonia	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Nervous system disorders Brain Hypoxia	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Nervous system disorders Cerebrovascular Accident	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Nervous system disorders Seizure	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.

Other adverse events

Other adverse events
Measure	JUVEDERM VOLIFT® XC During Initial/Touch Up n=123 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.	Control During Initial/Touch Up Treatment Period n=123 participants at risk Nasolabial folds treated with Control during the Initial/Touch Up period.	Not at NLF During Initial/Touch Up Treatment Period n=123 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.	JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment n=93 participants at risk Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
General disorders Injection Site Induration	10.6% 13/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	8.9% 11/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	10.8% 10/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
General disorders Injection Site Mass	7.3% 9/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	7.3% 9/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	9.7% 9/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
General disorders Injection Site Swelling	7.3% 9/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	7.3% 9/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	3.2% 3/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.
General disorders Injection Site Bruising	4.1% 5/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.81% 1/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	0.00% 0/123 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.	5.4% 5/93 The Safety Population includes all subjects who received at least 1 treatment. The Safety Population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are presented by treatment side for events occurring at the nasolabial folds, or combined for events that did not occur at the nasolabial folds.

Additional Information

Allergan Inc.,

Allergan, Inc

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