Nasolabial FoldsPhase 4NCT02718040
Emervel for the Correction of Lower Face Wrinkles & Folds
A Phase 4 study testing Emervel Classic and/or Deep Treatment Group in people with Nasolabial Folds and Marionette Lines, run by Galderma R&D.
Trial summary
This study is designed to 1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment 2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment 3. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds, Marionette Lines, Wrinkles
- What is being tested?
- Emervel Classic and/or Deep Treatment Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Aug 2016
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
- Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
- Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.
Who cannot join
- Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
- Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
- Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
- Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
- Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
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- Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.
- Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
- Other condition preventing the subject from entering the study in the treating investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
About this study
Official title: A Multi-Center Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
This study is designed to
- evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
- evaluate naturalness of facial expressions (photographs), by treating investigator assessment
- evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
- evaluate aesthetic improvement, by subject and treating investigator assessments
- evaluate subject satisfaction
- evaluate nasolabial fold (NLF) severity, by treating investigator assessment
- evaluate marionette lines (MLs) severity, by treating investigator assessment
- evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
- evaluate all adverse events reported during the study.
- Conditions
- Nasolabial Folds, Marionette Lines, Wrinkles
- Being tested
- Emervel Classic and/or Deep Treatment Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel Classic and/or Deep Treatment GroupDevice
Severity of Wrinkle Severity treated by product type:
Emervel Classic:
Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3
Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4
Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)
| Study group | Role | What they receive |
|---|---|---|
| Emervel Treatment Group | Experimental | Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep Receives: Device: Emervel Classic and/or Deep Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Naturalness of Expression in Motion (2D Video)
Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator
Measured: 42 days
Secondary outcomes (9)
Number of Subjects With Naturalness of Expression (Photographs)
Proportion of subjects having at least maintained naturalness of facial expression based on photograph assessment at Day 42, by treating investigator
Measured: 42 days
Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)
Proportion of subjects having at least maintained naturalness of expression in the lower face (naturalness is maintained or enhanced) AND attractiveness of the lower face is enhanced AND age of the lower face is younger, based on 2D video assessment at Day 42, by the treating investigator. The is a composite perception assessment; the proportion of subjects must meet all 3 criteria (maintain naturalness, maintain attractiveness, and appear younger in the lower face.
Measured: 42 days
Number of Subjects Reporting Global Improvement (Subject)
Aesthetic improvement assessed by subject using the Global Aesthetic Improvement Scale (GAIS). The subject reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved.
Measured: 42 days
Number of Subjects Demonstrating Global Improvement (Treating Investigator)
Aesthetic improvement assessed by treating investigator using the Global Aesthetic Improvement Scale (GAIS). The treating investigator reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved.
Measured: 42 days
Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural
Proportion of subjects responding with Strongly Agree or Agree. Subject reported satisfaction using a 5-point Likert scale questionnaire. Responses were 1-strongly disagree, 2-disagree, 3-neutral, 4-agree, and 5-strongly agree.
Measured: 42 days
Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Severity Rating Scale (WSRS). Assessments of both NLFs were graded according the following responses: 1-absent, 2-mild, 3-moderate, 4-severe, and 5-extreme. WSRS improvement from baseline included 1-grade improvement (reduction in WSRS) from baseline.
Measured: 42 days
Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Assessment Scale (WAS). Assessments of both MLs were graded according the following responses: 0-no wrinkles, 1-just perceptible wrinkle, 2-shallow wrinkle, 3, moderately deep wrinkle, 4-deep wrinkle, well defined edges, 5-very deep wrinkle, redundant fold. WAS improvement from baseline included 1-grade improvement (reduction in WAS) from baseline.
Measured: 42 days
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment)
Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, NLF). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging.
Measured: baseline and 42 days
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment)
Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, ML). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging.
Measured: baseline and 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionAug 2016
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 Nasolabial FoldsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Mashburn, Study director, Galderma Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718040
- Sponsor's protocol ID
- GLI.04.SPR.US10345
- Status last verified
- Sep 2018
- First submitted
- 16 Mar 2016
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
- ClinicalTrials.gov ID
- NCT02718040
- Acronym / sponsor ID
- GLI.04.SPR.US10345
- Conditions
- Nasolabial Folds, Marionette Lines, Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Posted 25 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to
- evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
- evaluate naturalness of facial expressions (photographs), by treating investigator assessment
- evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
- evaluate aesthetic improvement, by subject and treating investigator assessments
- evaluate subject satisfaction
- evaluate nasolabial fold (NLF) severity, by treating investigator assessment
- evaluate marionette lines (MLs) severity, by treating investigator assessment
- evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
- evaluate all adverse events reported during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emervel Treatment Group | Experimental | Device: Emervel Classic and/or Deep Treatment GroupEligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
- Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
- Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.
Key exclusion criteria (9 listed)
- Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
- Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
- Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
- Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
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 Classic and/or Deep Treatment GroupSeverity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product) | Device | Emervel Treatment Group |
Primary outcome
Number of Subjects With Naturalness of Expression in Motion (2D Video)
Time frame: 42 days
Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator
9 secondary outcomes
Number of Subjects With Naturalness of Expression (Photographs)
Time frame: 42 days
Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)
Time frame: 42 days
Number of Subjects Reporting Global Improvement (Subject)
Time frame: 42 days
Number of Subjects Demonstrating Global Improvement (Treating Investigator)
Time frame: 42 days
Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural
Time frame: 42 days
Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
Time frame: 42 days
Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
Time frame: 42 days
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment)
Time frame: baseline and 42 days
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment)
Time frame: baseline and 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- 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.
Jay Mashburn study director
Galderma Laboratories
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emervel Classic and/or Deep Treatment Group in people with Nasolabial Folds and Marionette Lines, run by Galderma R&D.
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 9 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 25 Sep 2018). 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?
Number of Subjects With Naturalness of Expression in Motion (2D Video) (time frame: 42 days). 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 1 Aug 2022.