Moderate to Severe Nasolabial FoldsNCT01976663

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

A study testing JUVEDERM VOLIFT® XC in people with Moderate to Severe Nasolabial Folds, run by Allergan at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Moderate to Severe Nasolabial Folds
What is being tested?: JUVEDERM VOLIFT® XC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 7 sitesUnited States
Study dates: 29 Oct 2013to 26 Oct 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Total Skin and Beauty Dermatology Center P.C.
Birmingham, Alabama, 35205
Study site
Chicago, Illinois, 60611
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
Skin Research Institute
Coral Gables, Florida, 33146
Vitiligo and Pigmentation Institute of Southern California
Los Angeles, California, 90036
Study site
San Francisco, California, 94115
Study site
West Palm Beach, Florida, 33401

Other trials in United States

About this study

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

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).

Conditions: Moderate to Severe Nasolabial Folds
Being tested: JUVEDERM VOLIFT® XC, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JUVEDERM VOLIFT® XCDevice
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.
ControlDevice
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.

Study groups in NCT01976663
Study group	Role	What they receive
VOLIFT® XC NLFs	Experimental	Nasolabial folds treated with JUVEDERM VOLIFT® XC. Receives: Device: JUVEDERM VOLIFT® XC
Control NLFs	Active comparator	Nasolabial folds treated with Control. Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
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.
Measured: Baseline, Month 6
Percentage of Nasolabial Folds With ≥1-Point Improvement
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.
Measured: Baseline, Month 6

Secondary outcomes (2)

Percentage of Nasolabial Folds With ≥1-Point Improvement
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.
Measured: Baseline, Month 12
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
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.
Measured: Baseline, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 201326 Oct 2015

First posted6 Nov 2013 (estimated)
Study start29 Oct 2013
Primary completion17 Mar 2015
Study completion26 Oct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Moderate to Severe Nasolabial FoldsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01976663
Sponsor's protocol ID: S17L-001
Status last verified: Mar 2019
First submitted: 30 Oct 2013
Last updated: 10 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 29701621

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
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Filler Post Market Survey (FIPS)
Wrinkle Reduction
Active, not recruiting
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Recruiting
CelluJuve® for the Treatment of Moderate to Severe NLFs
Nasolabial Fold Wrinkles
Not yet recruiting
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles

All Moderate to Severe Nasolabial Folds trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01976663
Acronym / sponsor ID: S17L-001
Conditions: Moderate to Severe Nasolabial Folds
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 29 Oct 2013 (actual)
Primary completion: 17 Mar 2015 (actual)
Study completion: 26 Oct 2015 (actual)
First posted: 6 Nov 2013 (estimated)
Results: Posted 22 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VOLIFT® XC NLFs	Experimental	Device: JUVEDERM VOLIFT® XCNasolabial folds treated with JUVEDERM VOLIFT® XC.
Control NLFs	Active comparator	Device: ControlNasolabial folds treated with Control.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JUVEDERM VOLIFT® XCUp 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.	Device	VOLIFT® XC NLFs
ControlUp 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.	Device	Control NLFs

Primary outcome

Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)
Time frame: 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.
Percentage of Nasolabial Folds With ≥1-Point Improvement
Time frame: 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.

2 secondary outcomes

Percentage of Nasolabial Folds With ≥1-Point Improvement
Time frame: Baseline, Month 12
Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score
Time frame: Baseline, Month 12

Results and safety

Results posted to the registry on 22 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JUVEDERM VOLIFT® XC	126	84

Primary outcome: Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)

Time frame: Baseline, Month 6. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	JUVEDERM VOLIFT® XC n = 123	Control n = 123
Baseline	2.6 (0.49)	2.6 (0.49)
Month 6 (N=117, 117)	1.4 (0.67)	1.3 (0.72)

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

Primary outcome: Percentage of Nasolabial Folds With ≥1-Point Improvement

Time frame: Baseline, Month 6. Number (95% Confidence Interval). Unit: Percentage of Nasolabial Folds

Measure	JUVEDERM VOLIFT® XC n = 117	Control n = 117
Value	93.2 (0.49)	86.3 (78.7 to 92.0)

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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JUVEDERM VOLIFT® XC During Initial/Touch Up	0 of 123 (0%)	29 of 123 (23.6%)	Not reported
Control During Initial/Touch Up Treatment Period	0 of 123 (0%)	27 of 123 (22%)	Not reported
Not at NLF During Initial/Touch Up Treatment Period	5 of 123 (4.1%)	0 of 123 (0%)	Not reported
JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment	0 of 93 (0%)	19 of 93 (20.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29701621Monheit 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing JUVEDERM VOLIFT® XC in people with Moderate to Severe Nasolabial Folds, run by Allergan at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS) (time frame: Baseline, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.