Nasolabial FoldsNCT00653861
Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
A study testing JUVÉDERM™ Injectable Gel with Lidocaine and JUVÉDERM™ Injectable Gel in people with Nasolabial Folds, run by Allergan Medical at 1 site in United States.
Trial summary
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment 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?
- JUVÉDERM™ Injectable Gel with Lidocaine and JUVÉDERM™ Injectable Gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2008
- 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
- Be male or female, 18 years of age or older
- Desire correction of moderate to severe nasolabial folds (NLFs)
- Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score
Who cannot join
- Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
- Begin 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 are planning to begin use of such products during the study.
- Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
- Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
- Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo desensitization therapy during the term of the study.
- Have an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound in the NLF area
Trial locations and contacts
1 site in 1 country.
About this study
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
Read the detailed description
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.
- Conditions
- Nasolabial Folds
- Being tested
- JUVÉDERM™ Injectable Gel with Lidocaine, JUVÉDERM™ Injectable Gel
- Keywords
- Aesthetic correction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUVÉDERM™ Injectable Gel with LidocaineDevice
Single treatment, volume determined by investigator
JUVÉDERM™ Injectable GelDevice
Single treatment, volume determined by investigator
| Study group | Role | What they receive |
|---|---|---|
| Juvederm with Lidocaine | Experimental | Subjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold. Receives: Device: JUVÉDERM™ Injectable Gel with Lidocaine |
| Juvederm | Active comparator | Subjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold. Receives: Device: JUVÉDERM™ Injectable Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain Score
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Measured: 1 day
Secondary outcomes (2)
Comparative Pain
A 5-point scale (-2 = Right NLF more painful than Left NLF; -1 = Right NLF slightly more painful than Left NLF; 0 = No difference; 1 = Left NLF slightly more painful than Right NLF; 2 = Left NLF more painful than Right NLF). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.
Measured: 1 day
Nasolabial Fold (NLF) Severity
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 Juvederm with Lidocaine (either Ultra or Ultra Plus) in one nasolabial fold and Juvederm (either Ultra or Ultra Plus) in the other nasolabial fold.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJul 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653861
- Sponsor's protocol ID
- JULIDO-001
- Status last verified
- Dec 2013
- First submitted
- 2 Apr 2008
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.
PubMed 19735519
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of JUVÉDERM™ Injectable Gel With Lidocaine
- ClinicalTrials.gov ID
- NCT00653861
- Acronym / sponsor ID
- JULIDO-001
- Conditions
- Nasolabial Folds
- Keywords
- Aesthetic correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Apr 2008 (estimated)
- Results
- Posted 30 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and effectiveness of JUVÉDERM™ Injectable Gel with Lidocaine compared to JUVÉDERM™ without Lidocaine for procedural pain in the treatment of nasolabial folds.
Detailed description
Controlled, randomized, split-face study in which subjects receive JUVÉDERM™ Injectable Gel with Lidocaine (Ultra or Ultra Plus) in one nasolabial fold and JUVÉDERM™ Injectable Gel without Lidocaine (Ultra or Ultra Plus) in the other nasolabial fold. The investigator determines whether the subject receives JUVÉDERM™ Ultra or Ultra Plus per the level of correction desired; the lidocaine assignment is randomized.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juvederm with Lidocaine | Experimental | Device: JUVÉDERM™ Injectable Gel with LidocaineSubjects receive Juvederm with Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in one nasolabial fold. |
| Juvederm | Active comparator | Device: JUVÉDERM™ Injectable GelSubjects receive Juvederm without Lidocaine (either Ultra or Ultra Plus at investigator's discretion) in the other nasolabial fold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be male or female, 18 years of age or older
- Desire correction of moderate to severe nasolabial folds (NLFs)
- Have approximately symmetrical NLFs, i.e., both NLFs have the same pretreatment NLF severity score
Key exclusion criteria (6 listed)
- Have undergone cosmetic facial procedures in the lower 2/3 of the face within 1 month prior to entry in the study or are planning to undergo these procedure during the study.
- Begin 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 are planning to begin use of such products during the study.
- Have undergone previous hyaluronic acid (HA)-based dermal filler treatments such that the total volume of HA injected within 12 months prior to study entry is within 5 mL of the recommended annual maximum volume for HA dermal fillers.
- Has ever received semi-permanent fillers or permanent facial implants anywhere in the face or neck, or is planning to be implanted with these products during the study.
- Have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or Streptococcal protein, or have plans to undergo 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 |
|---|---|---|
| JUVÉDERM™ Injectable Gel with LidocaineSingle treatment, volume determined by investigator | Device | Juvederm with Lidocaine |
| JUVÉDERM™ Injectable GelSingle treatment, volume determined by investigator | Device | Juvederm |
Primary outcome
Procedural Pain Score
Time frame: 1 day
Evaluate pain on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.
2 secondary outcomes
Comparative Pain
Time frame: 1 day
Nasolabial Fold (NLF) Severity
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19735519Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10. doi: 10.1111/j.1473-2165.2009.00451.x.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUVÉDERM™ Injectable Gel with Lidocaine and JUVÉDERM™ Injectable Gel in people with Nasolabial Folds, run by Allergan Medical at 1 site 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 3 inclusion and 6 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 13 Oct 2014. 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 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 30 Dec 2009). 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 NCT00653861, 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 13 Oct 2014.