Moderate to Severe Nasolabial FoldsNCT01680497
Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds
A study testing Crosslinked hyaluronic acid dermal filler in people with Moderate to Severe Nasolabial Folds, run by Allergan at 3 sites in 2 countries.
Trial summary
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Nasolabial Folds
- What is being tested?
- Crosslinked hyaluronic acid dermal filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2012to 6 Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
- Conditions
- Moderate to Severe Nasolabial Folds
- Being tested
- Crosslinked hyaluronic acid dermal filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked hyaluronic acid dermal fillerDevice
Also called JUVÉDERM VOLIFT™
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.
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM VOLIFT™ | Experimental | All subjects receiving treatment with JUVÉDERM VOLIFT™. Receives: Device: Crosslinked hyaluronic acid dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
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).
Measured: Month 12
Secondary outcomes (6)
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
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).
Measured: Day 0, Day 14, Month 1, Month 9
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
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).
Measured: Day 14, Month 1, Month 9, Month 12
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).
Measured: Day 0, Day 14
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
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).
Measured: Day 0, Day 14, Month 1, Month 9, Month 12
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
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).
Measured: Day 14, Month 1, Month 9, Month 12
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
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).
Measured: Day 0, Day 14, Month 12, Month 12.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study start1 Jun 2012
- Primary completion6 Mar 2014
- Study completion6 Mar 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Allergan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680497
- Sponsor's protocol ID
- MAF/AGN/MED/FIL/018
- Status last verified
- Apr 2019
- First submitted
- 4 Sep 2012
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 28165349
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01680497
- Acronym / sponsor ID
- MAF/AGN/MED/FIL/018
- Conditions
- Moderate to Severe Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 6 Mar 2014 (actual)
- Study completion
- 6 Mar 2014 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 23 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label, multi-center, observational, post-market study evaluating JUVÉDERM VOLIFT™ for the correction of moderate to severe nasolabial folds
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM VOLIFT™ | Experimental | Device: Crosslinked hyaluronic acid dermal fillerAll subjects receiving treatment with JUVÉDERM VOLIFT™. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| Crosslinked hyaluronic acid dermal fillerAlso: JUVÉDERM VOLIFT™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. | Device | JUVÉDERM VOLIFT™ |
Primary outcome
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)
Time frame: 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).
6 secondary outcomes
Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Time frame: Day 0, Day 14, Month 1, Month 9
Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale
Time frame: Day 14, Month 1, Month 9, Month 12
Investigator Assessment of Ease of Injection Use on a 10-Point Scale
Time frame: Day 0, Day 14
Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS
Time frame: Day 0, Day 14, Month 1, Month 9, Month 12
Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale
Time frame: Day 14, Month 1, Month 9, Month 12
Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale
Time frame: Day 0, Day 14, Month 12, Month 12.5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28165349Sattler 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.
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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.
Medical Monitor study director
Allergan Medical
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosslinked hyaluronic acid dermal filler in people with Moderate to Severe Nasolabial Folds, run by Allergan at 3 sites in 2 countries.
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 6 inclusion and 21 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands. 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 23 Jun 2015). 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?
Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS) (time frame: Month 12). 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 NCT01680497, 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 16 Apr 2019.