Nasolabial FoldsPhase 4NCT00850889
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
A Phase 4 study testing Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine and A gel of hyaluronic acid (concentration of 20 mg/mL) in people with Nasolabial Folds, run by Allergan Medical at 1 site in Canada.
Trial summary
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of 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
- Nasolabial Folds
- What is being tested?
- Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine and A gel of hyaluronic acid (concentration of 20 mg/mL)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Nov 2008
- Phase
- Phase 4
- 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
- Desires correction of moderate to severe nasolabial folds (NLFs)
- Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
- Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study
Who cannot join
- Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
- Initiating use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the study
- Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
- Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
- Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
- Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
- Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
- Conditions
- Nasolabial Folds
- Being tested
- Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine, A gel of hyaluronic acid (concentration of 20 mg/mL)
- Keywords
- Aesthetic correction of nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaineDevice
Also called Juvederm® Ultra Injectable Gel with Lidocaine
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
A gel of hyaluronic acid (concentration of 20 mg/mL)Device
Also called Restylane® Injectable Gel
Day 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Juvederm Ultra Injectable Gel with Lidocaine Receives: Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine |
| 2 | Active comparator | Restylane Injectable Gel Receives: Device: A gel of hyaluronic acid (concentration of 20 mg/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain Score
Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 1 day
Secondary outcomes (3)
Comparative Pain
A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Measured: 1 day
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity
Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Measured: Day 0, Day 14
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity
Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF
Measured: Day 0, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2008
- Study completionNov 2008
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 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850889
- Sponsor's protocol ID
- MA-JULIDO-0801
- Status last verified
- Dec 2018
- First submitted
- 23 Feb 2009
- Last updated
- 9 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9.
PubMed 20936295
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT00850889
- Acronym / sponsor ID
- MA-JULIDO-0801
- Conditions
- Nasolabial Folds
- Keywords
- Aesthetic correction of nasolabial folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 21 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaineJuvederm Ultra Injectable Gel with Lidocaine |
| 2 | Active comparator | Device: A gel of hyaluronic acid (concentration of 20 mg/mL)Restylane Injectable Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Desires correction of moderate to severe nasolabial folds (NLFs)
- Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
- Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study
Key exclusion criteria (7 listed)
- Cosmetic facial procedures [e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
- Initiating use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the study
- Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
- Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
- Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
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 |
|---|---|---|
| Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaineAlso: Juvederm® Ultra Injectable Gel with LidocaineDay 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL | Device | 1 |
| A gel of hyaluronic acid (concentration of 20 mg/mL)Also: Restylane® Injectable GelDay 0, maximum total volume (dosage) allowed for each NLF is 1.6 mL | Device | 2 |
Primary outcome
Procedural Pain Score
Time frame: 1 day
Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
3 secondary outcomes
Comparative Pain
Time frame: 1 day
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity
Time frame: Day 0, Day 14
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity
Time frame: Day 0, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20936295Smith SR, Jones D, Thomas JA, Murphy DK, Beddingfield FC 3rd. Duration of wrinkle correction following repeat treatment with Juvederm hyaluronic acid fillers. Arch Dermatol Res. 2010 Dec;302(10):757-62. doi: 10.1007/s00403-010-1086-8. Epub 2010 Oct 9.
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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 Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine and A gel of hyaluronic acid (concentration of 20 mg/mL) in people with Nasolabial Folds, run by Allergan Medical at 1 site in Canada.
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 3 inclusion and 7 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2011). 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?
Procedural Pain Score (time frame: 1 day). 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 NCT00850889, 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 9 Jan 2019.