Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01680497
• Collaborator: (none)
• Enrollment: 70
• Locations: 3
• Arm: 1
• Actual Duration (Months): 21.1
• Patients Per Site: 23.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Nasolabial Folds	Device: Crosslinked hyaluronic acid dermal filler	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Mar 6, 2014
• Actual Study Completion Date: Mar 6, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JUVÉDERM VOLIFT™ All subjects receiving treatment with JUVÉDERM VOLIFT™.	Device: Crosslinked hyaluronic acid dermal filler; All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.; Other Names: JUVÉDERM VOLIFT™

Outcome Measures

Primary Outcome Measures

1. Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) [Month 12]

   Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).

Secondary Outcome Measures

1. Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS [Day 0, Day 14, Month 1, Month 9]

   Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).

2. Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale [Day 14, Month 1, Month 9, Month 12]

   Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).

3. Investigator Assessment of Ease of Injection Use on a 10-Point Scale [Day 0, Day 14]

   Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).

4. Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS [Day 0, Day 14, Month 1, Month 9, Month 12]

   Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).

5. Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale [Day 14, Month 1, Month 9, Month 12]

   Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).

6. Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale [Day 0, Day 14, Month 12, Month 12.5]

   Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female 18 years of age or older

• Have 2 fully visible, approximately symmetrical nasolabial folds and has severity scores of 2 or 3 on the 5-point photographic nasolabial fold severity scale (range 0-4) for both nasolabial folds, as judged by the Investigator

• Have a reasonable expectation for correction by injection via deep dermis, as described in the protocol

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

• Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent prior to any study-related procedures being performed

• Be in good health as in the opinion of the Investigator

Exclusion Criteria:

• Has undergone cosmetic facial procedures (e.g., face lift or other surgeries) which may alter the appearance of the nasolabial fold area

• Cosmetic injections in the lower two-thirds of the face (below the orbital rim), within 6 months prior to entry in the study, or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry

• Has undergone volumizing of the mid/lower face within 9 months prior to study entry

• Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded poly-tetrafluoroethylene) anywhere in the lower face (below the orbital rim), or be planning to be implanted with any of these products at any time during the study

• Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to lidocaine (an any amide-based anesthetics), HA products, or Streptococcal protein, or be planning to undergo a desensitization therapy during the term of the study

• Be a pregnant female, lactating, or planning to become pregnant at any time during the study

• Be a female of childbearing potential not using a reliable means of contraception

• Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study

• Suffer from an uncontrolled personality disorder (e.g., body dysmorphia, depression)

• Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease)

• Have a history of streptococcal disease (e.g., strep throat or rheumatic fever with or without heart complications)

• Have a history of skin cancer

• Suffer from porphyria

• Have epilepsy, which is not controlled by anti-epilepsy therapy

• Current cutaneous inflammatory and/or infectious processes (e.g., acne, herpes)

• Have a history of treatment with interferon

• Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo biloba) within 10 days of undergoing study device injection. NOTE: Study device injection may be delayed as necessary to accommodate this 10-day period

• Be on a concurrent regimen of high doses of lidocaine (more than 400 mg) which may cause acute toxic reactions

• Be on a concurrent regimen of other local anesthetics structurally related to amide-type local anesthetics

• Have impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction

• Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Darmstadt		Germany
2		Koln		Germany
3		Naarden		Netherlands

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Monitor, Allergan Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

• Sattler G, Philipp-Dormston WG, Van Den Elzen H, Van Der Walt C, Nathan M, Kolodziejczyk J, Kerson G, Dhillon B. A Prospective, Open-Label, Observational, Postmarket Study Evaluating VYC-17.5L for the Correction of Moderate to Severe Nasolabial Folds Over 12 Months. Dermatol Surg. 2017 Feb;43(2):238-245. doi: 10.1097/DSS.0000000000000939.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01680497
• Other Study ID Numbers: MAF/AGN/MED/FIL/018
• First Posted: Sep 7, 2012
• Last Update Posted: Apr 16, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Period Title: Overall Study
STARTED	70
COMPLETED	68
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Overall Participants	70
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.3 (9.5)
Sex: Female, Male (Count of Participants)
Female	66 94.3%
Male	4 5.7%

Outcome Measures

1. Primary Outcome

Title	Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
Description	Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	65
12 Months - Right	2.8 (0.8)
12 Months - Left	2.8 (0.8)

2. Secondary Outcome

Title	Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Description	Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time Frame	Day 0, Day 14, Month 1, Month 9

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Day 0 - Right	3.6 (0.5)
Day 0 -Left	3.7 (0.5)
Day 14 - Right	1.7 (0.5)
Day 14 - Left	1.7 (0.5)
Month 1 - Right (N=66)	1.8 (0.6)
Month 1 - Left (N=66	1.9 (0.6)
Month 9 - Right (N=66)	2.5 (0.7)
Month 9 - Left (N=66)	2.4 (0.7)

3. Secondary Outcome

Title	Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Description	Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Time Frame	Day 14, Month 1, Month 9, Month 12

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Day 14	4.6 (0.6)
Month 1 (N=66)	4.5 (0.7)
Month 9 (N=65)	4.0 (1.1)
Month 12 (N=65)	4.4 (1.0)

4. Secondary Outcome

Title	Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Description	Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
Time Frame	Day 0, Day 14

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Day 0	1.2 (1.3)
Day 14 (N=27)	0.9 (0.5)

5. Secondary Outcome

Title	Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Description	Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).
Time Frame	Day 0, Day 14, Month 1, Month 9, Month 12

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Day 0 - Right	3.8 (0.7)
Day 0 - Left	3.9 (0.7)
Day 14 - Right	1.8 (0.7)
Day 14 - Left	1.8 (0.7)
Month 1 - Right (N=66)	2.0 (0.9)
Month 1 - Left (N=65)	2.1 (0.8)
Month 9 - Right (N=66)	2.6 (0.8)
Month 9 - Left (N=66)	2.6 (0.8)
Month 12 - Right (N=54)	2.9 (0.8)
Month 12 - Left (N=54)	3.0 (0.9)

6. Secondary Outcome

Title	Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Description	Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).
Time Frame	Day 14, Month 1, Month 9, Month 12

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Day 14	4.2 (1.0)
Month 1 (N=66)	4.2 (1.0)
Month 9 (N=66)	3.2 (2.4)
Month 12 (N=54)	3.3 (1.9)

7. Secondary Outcome

Title	Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Description	Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).
Time Frame	Day 0, Day 14, Month 12, Month 12.5

Outcome Measure Data

Analysis Population Description

Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point

Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
Measure Participants	67
Pain Intensity Day 0 - Right	2.0 (1.8)
Pain Intensity Day 0 - Left	2.0 (1.8)
Pain Intensity Day 14 - Right (N=66)	0.8 (1.7)
Pain Intensity Day 14 - Left (N=66)	0.7 (1.5)
Pain Intensity Month 12 - Right (N=51)	1.5 (1.8)
Pain Intensity Month 12 - Left (N=51)	1.5 (2.1)
Pain Intensity Month 12.5 - Right (N=12)	0.0 (0.0)
Pain Intensity Month 12.5 - Left (N=12)	0.0 (0.0)
Swelling Intensity Day 0 - Right	1.7 (1.6)
Swelling Intensity Day 0 - Left	1.7 (1.6)
Swelling Intensity Day 14 - Right (N=66)	1.5 (2.2)
Swelling Intensity Day 14 - Left (N=66)	1.4 (2.2)
Swelling Intensity Month 12 - Right (N=51)	1.4 (1.5)
Swelling Intensity Month 12 - Left (N=51)	1.4 (1.6)
Swelling Intensity Month 12.5 - Right (N=12)	0.1 (0.3)
Swelling Intensity Month 12.5 - Left (N=12)	0.2 (0.4)
Bruising Intensity Day 0 - Right	0.3 (0.9)
Bruising Intensity Day 0 - Left	0.3 (0.9)
Bruising Intensity Day 14 - Right (N=66)	0.9 (1.9)
Bruising Intensity Day 14 - Left (N=66)	0.5 (1.3)
Bruising Intensity Month 12 - Right (N=51)	0.4 (0.8)
Bruising Intensity Month 12 - Left (N=51)	0.4 (0.9)
Bruising Intensity Month 12.5 - Right (N=12)	0.3 (0.7)
Bruising Intensity Month 12.5 - Left (N=12)	0.5 (0.8)

Adverse Events

Adverse Event Reporting Description	The Safety Population is used to assess adverse events (AEs) and serious adverse events (SAEs) and includes all treated subjects.
Arm/Group Title	JUVÉDERM VOLIFT™
Arm/Group Description	All subjects receiving treatment with JUVÉDERM VOLIFT™.
All Cause Mortality
	JUVÉDERM VOLIFT™
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	JUVÉDERM VOLIFT™
	Affected / at Risk (%)	# Events
Total	0/70 (0%)
Other (Not Including Serious) Adverse Events
	JUVÉDERM VOLIFT™
	Affected / at Risk (%)	# Events
Total	0/70 (0%)

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.