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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01976663
• Collaborator: (none)
• Enrollment: 126
• Locations: 7
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site: 18
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

A prospective, multicenter, within-subject controlled study of the safety and effectiveness of JUVÉDERM VOLIFT® XC versus Control for the correction of moderate to severe nasolabial folds (NLFs).

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Nasolabial Folds	Device: JUVEDERM VOLIFT® XC; Device: Control	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Within-subject Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLIFT® XC Versus Control for the Correction of Moderate to Severe Nasolabial Folds
• Actual Study Start Date: Oct 29, 2013
• Actual Primary Completion Date: Mar 17, 2015
• Actual Study Completion Date: Oct 26, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VOLIFT® XC NLFs Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Device: JUVEDERM VOLIFT® XC; Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.
Active Comparator: Control NLFs Nasolabial folds treated with Control.	Device: Control; Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) [Baseline, Month 6]

   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.

2. Percentage of Nasolabial Folds With ≥1-Point Improvement [Baseline, Month 6]

   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.

Secondary Outcome Measures

1. Percentage of Nasolabial Folds With ≥1-Point Improvement [Baseline, Month 12]

   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.

2. Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score [Baseline, Month 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 2 visible moderate to severe nasolabial folds

• Agree to refrain from undergoing other anti-wrinkle/volumizing treatments in the lower two-thirds of the face for the duration of the study

Exclusion Criteria:

• Undergone facial tissue augmentation with dermal fillers in the lower two-thirds of the face within the past 12 months

• Undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower two-thirds of the face, mesotherapy, or cosmetic facial procedures in the face or neck within the past 6 months

• Received semi-permanent fillers or permanent facial implants anywhere in the lower face

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Total Skin and Beauty Dermatology Center P.C.	Birmingham	Alabama	United States	35205
2	Vitiligo and Pigmentation Institute of Southern California	Los Angeles	California	United States	90036
3		San Francisco	California	United States	94115
4	Dermatology Research Institute, LLC	Coral Gables	Florida	United States	33146
5	Skin Research Institute	Coral Gables	Florida	United States	33146
6		West Palm Beach	Florida	United States	33401
7		Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Allergan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Monheit G, Beer K, Hardas B, Grimes PE, Weichman BM, Lin V, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. Dermatol Surg. 2018 May;44(5):670-678. doi: 10.1097/DSS.0000000000001529.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01976663
• Other Study ID Numbers: S17L-001
• First Posted: Nov 6, 2013
• Last Update Posted: May 10, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	JUVEDERM VOLIFT® XC
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
Period Title: Overall Study
STARTED	126
Received Touch-up Treatment	63
Received Asymmetry Correction	45
Received Repeat Treatment	85
COMPLETED	84
NOT COMPLETED	42

Baseline Characteristics

Arm/Group Title	JUVEDERM VOLIFT® XC
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
Overall Participants	123
Age, Customized (Count of Participants)
30 to 50 years	36 29.3%
51 to 65 years	72 58.5%
>65 years	15 12.2%
Sex: Female, Male (Count of Participants)
Female	117 95.1%
Male	6 4.9%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
Description	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.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JUVEDERM VOLIFT® XC	Control
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Nasolabial folds treated with Control.
Measure Participants	123	123
Baseline	2.6 (0.49)	2.6 (0.49)
Month 6 (N=117, 117)	1.4 (0.67)	1.3 (0.72)

2. Primary Outcome

Title	Percentage of Nasolabial Folds With ≥1-Point Improvement
Description	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.
Time Frame	Baseline, Month 6

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JUVEDERM VOLIFT® XC	Control
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Nasolabial folds treated with Control.
Measure Participants	117	117
Number (95% Confidence Interval) [Percentage of Nasolabial Folds]	93.2 (0.49)	86.3

3. Secondary Outcome

Title	Percentage of Nasolabial Folds With ≥1-Point Improvement
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JUVEDERM VOLIFT® XC	Control
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Nasolabial folds treated with Control.
Measure Participants	113	113
Number (95% Confidence Interval) [Percentage of Nasolabial Folds]	57.5 (0.49)	56.6

4. Secondary Outcome

Title	Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	JUVEDERM VOLIFT® XC	Control
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC.	Nasolabial folds treated with Control.
Measure Participants	123	123
Baseline	32.1 (14.70)	32.0 (14.94)
Month 12 (N=112, 111)	25.8 (23.08)	23.4 (22.83)

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	JUVEDERM VOLIFT® XC During Initial/Touch Up		Control During Initial/Touch Up Treatment Period		Not at NLF During Initial/Touch Up Treatment Period		JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment
Arm/Group Description	Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.		Nasolabial folds treated with Control during the Initial/Touch Up period.		Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.		Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
All Cause Mortality
	JUVEDERM VOLIFT® XC During Initial/Touch Up		Control During Initial/Touch Up Treatment Period		Not at NLF During Initial/Touch Up Treatment Period		JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	JUVEDERM VOLIFT® XC During Initial/Touch Up		Control During Initial/Touch Up Treatment Period		Not at NLF During Initial/Touch Up Treatment Period		JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/123 (0%)		0/123 (0%)		5/123 (4.1%)		0/93 (0%)
Cardiac disorders
Cardiac Arrest	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Infections and infestations
Diverticulitis	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Pneumonia	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Squamous Cell Carcinoma	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Nervous system disorders
Brain Hypoxia	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Cerebrovascular Accident	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Seizure	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Reproductive system and breast disorders
Ovarian Cyst	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Respiratory, thoracic and mediastinal disorders
Aspiration	0/123 (0%)		0/123 (0%)		1/123 (0.8%)		0/93 (0%)
Other (Not Including Serious) Adverse Events
	JUVEDERM VOLIFT® XC During Initial/Touch Up		Control During Initial/Touch Up Treatment Period		Not at NLF During Initial/Touch Up Treatment Period		JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/123 (23.6%)		27/123 (22%)		0/123 (0%)		19/93 (20.4%)
General disorders
Injection Site Induration	13/123 (10.6%)		11/123 (8.9%)		0/123 (0%)		10/93 (10.8%)
Injection Site Mass	9/123 (7.3%)		9/123 (7.3%)		0/123 (0%)		9/93 (9.7%)
Injection Site Swelling	9/123 (7.3%)		9/123 (7.3%)		0/123 (0%)		3/93 (3.2%)
Injection Site Bruising	5/123 (4.1%)		1/123 (0.8%)		0/123 (0%)		5/93 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.