Skin WrinklingNCT01205061
Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus in Treatment of Moderate to Severe Facial Wrinkles and Folds
A study testing Emervel Deep Lidocaine and Juvederm Ultra Plus in people with Skin Wrinkling, run by Galderma R&D at 11 sites in United States.
Trial summary
The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Wrinkling
- What is being tested?
- Emervel Deep Lidocaine and Juvederm Ultra Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 11 sitesUnited States
- Study dates
- 27 Sep 2010to 12 Jan 2012
- 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
- The subject was a male or female 18 years of age or older
- The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant
- The subject had the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold
Who cannot join
- The subject had active skin disease or inflammation on or near a nasolabial fold that, in the principal investigator's opinion, would interfere with the study device injections and/or study assessments.
- The subject had a history of sensitivity to hyaluronic acid
- The subject had a history of sensitivity to lidocaine or other amide type anesthetics
- The subject was, in the principal investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Galderma research site
Charlotte, North Carolina, 28207
Galderma research site
Hunt Valley, Maryland, 21030
Galderma research site
Los Angeles, California, 90036
Galderma research site
Miami Beach, Florida, 33140
Galderma research site
Nashville, Tennessee, 37215
Galderma research site
New Haven, Connecticut, 06511
Galderma research site
Plano, Texas, 75093
Galderma research site
San Francisco, California, 94115
Galderma research site
Snellville, Georgia, 30078
Galderma research site
Warren, Michigan, 48088
Galderma research site
White Plains, New York, 10604
About this study
Official title: A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and Folds
The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.
Read the detailed description
This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.
- Conditions
- Skin Wrinkling
- Being tested
- Emervel Deep Lidocaine, Juvederm Ultra Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel Deep LidocaineDevice
20 mg/mL + 0.3% lidocaine
Juvederm Ultra PlusDevice
24mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Emervel Deep Lidocaine | Experimental | NLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine). Receives: Device: Emervel Deep Lidocaine |
| Juvederm Ultra Plus | Active comparator | NLFs were injected with Juvéderm Ultra Plus (24 mg/mL). Receives: Device: Juvederm Ultra Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Measured: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Secondary outcomes (8)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Measured: Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Measured: Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Measured: Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection
WSRS is a nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Measured: Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
Participants self-assessment was measured by using a wrinkle severity scale with 1 being absent and 5 being extreme. Each participant was to perform an assessment of the wrinkle severity based on self-assessment score: 1= Absent (No visible fold; continuous skin line), 2= Mild (Shallow but visible fold with a slight indentation), 3= Moderate (Moderately deep folds), 4= Severe (Very long and deep fold), 5= Extreme (Extremely deep and long folds). A negative change from baseline indicates improvement.
Measured: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Participant Pain Assessment After the Initial Injection
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using an 11-point Numeric Pain Intensity Scale (NPIS).The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.
Measured: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)
Participant Pain Assessment After the Initial Touch-up Injection
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using NPIS. The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain where a lower score correlates to better outcome for pain.
Measured: At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection (At 3 weeks after initial injection)
Number of Participants With Adverse Event (AEs)
AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Number of participants with AEs were reported. Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."
Measured: From start of study drug administration up to 62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study start27 Sep 2010
- Primary completion20 Jun 2011
- Study completion12 Jan 2012
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.
- Other trials for Skin WrinklingStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, M.D., Study chair, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205061
- Sponsor's protocol ID
- RD.06.CIP.18159
- Status last verified
- Jul 2023
- First submitted
- 16 Sep 2010
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and Folds
- ClinicalTrials.gov ID
- NCT01205061
- Acronym / sponsor ID
- RD.06.CIP.18159
- Conditions
- Skin Wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2010 (actual)
- Primary completion
- 20 Jun 2011 (actual)
- Study completion
- 12 Jan 2012 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.
Detailed description
This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emervel Deep Lidocaine | Experimental | Device: Emervel Deep LidocaineNLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine). |
| Juvederm Ultra Plus | Active comparator | Device: Juvederm Ultra PlusNLFs were injected with Juvéderm Ultra Plus (24 mg/mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject was a male or female 18 years of age or older
- The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant
- The subject had the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold
Key exclusion criteria (4 listed)
- The subject had active skin disease or inflammation on or near a nasolabial fold that, in the principal investigator's opinion, would interfere with the study device injections and/or study assessments.
- The subject had a history of sensitivity to hyaluronic acid
- The subject had a history of sensitivity to lidocaine or other amide type anesthetics
- The subject was, in the principal investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
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 |
|---|---|---|
| Emervel Deep Lidocaine20 mg/mL + 0.3% lidocaine | Device | Emervel Deep Lidocaine |
| Juvederm Ultra Plus24mg/mL | Device | Juvederm Ultra Plus |
Primary outcome
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
Time frame: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
WSRS is a validated 5-point reference scale with photographs that classifies deep facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
8 secondary outcomes
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection
Time frame: Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection
Time frame: Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection
Time frame: Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection
Time frame: Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
Time frame: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Participant Pain Assessment After the Initial Injection
Time frame: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)
Participant Pain Assessment After the Initial Touch-up Injection
Time frame: At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection (At 3 weeks after initial injection)
Number of Participants With Adverse Event (AEs)
Time frame: From start of study drug administration up to 62 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Clinical Operations, M.D. study chair
Galderma R&D
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emervel Deep Lidocaine and Juvederm Ultra Plus in people with Skin Wrinkling, run by Galderma R&D at 11 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 3 inclusion and 4 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 23 Oct 2023). 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 Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection (time frame: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.