Nasolabial FoldsPhase 4NCT02672644
Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep
A Phase 4 study testing Emervel Classic and Emervel Deep in people with Nasolabial Folds and Wrinkles, run by Galderma R&D at 1 site in Canada.
Trial summary
Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep. 1. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds, Wrinkles
- What is being tested?
- Emervel Classic and Emervel Deep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, 35 to 60 years of age
- Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator
- Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
- Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1).
- If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows:
- use of oral/systemic contraceptives for at least 3 months prior to the start of the study; or
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- use of an intrauterine device; or
- use of double barrier (e.g., condom or diaphragm and spermicidal foam/gel, condom and diaphragm); or
- use of contraceptive implants or injectables for at least 28 days prior to the start of the study; or
- partner with vasectomy at least 3 months prior to study start; or
- strict abstinence.
- Females of child bearing potential must have negative urine pregnancy test (UPT) at Day 1 and Day 14 if touch-up is to be performed.
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 filler-type injectable product
- Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (12) months before treatment
- Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch, within six (6) months before treatment
- Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment
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- Subject who presents with severe midface volume loss
- Subject has a beard or facial hair that, in the investigator's opinion, would interfere with the study injections and/or study assessments
- Woman who plans to become pregnant during the study
- Woman who is pregnant or breast feeding
- 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
- Known/previous allergy or hypersensitivity to gram-positive bacterial proteins
- History of severe or multiple allergies manifested by anaphylaxis
- History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation within two (2) weeks before treatment
- Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment
- Any medical condition or treatment that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion
- Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor company
- Participation in any clinical study within thirty (30) days before treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.
- to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
- to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
- to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
- to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported
- to evaluate all adverse events during the course of the study
- Conditions
- Nasolabial Folds, Wrinkles
- Being tested
- Emervel Classic, Emervel Deep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel ClassicDevice
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)
Emervel DeepDevice
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).
| Study group | Role | What they receive |
|---|---|---|
| Emervel Classic | Experimental | Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling. Receives: Device: Emervel Classic |
| Emervel Deep | Experimental | Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling. Receives: Device: Emervel Deep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported time of return to social engagement after initial treatment
Time of return to social engagement (in hours)
Measured: 30 days
Secondary outcomes (6)
Change from baseline to post-treatment follow-up time points in subject reported GAIS
Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30
Measured: up to 30 days
Subject satisfaction with treatment outcome of the nasolabial folds
Subject satisfaction with treatment assessments at baseline, day 14, and day 30
Measured: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS
Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30
Measured: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS
Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30
Measured: 30 days
Incidence rate of subjects with adverse events (AEs)
Measured: 30 days
Incidence rate of subjects with injection-related adverse events
Injection-related adverse events recorded by the subject in study diary
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Author Swift, MD, Principal investigator, Arthur Swift Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672644
- Sponsor's protocol ID
- GLI.04.SPR.US10346
- Status last verified
- Jul 2016
- First submitted
- 26 Jan 2016
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
- ClinicalTrials.gov ID
- NCT02672644
- Acronym / sponsor ID
- GLI.04.SPR.US10346
- Conditions
- Nasolabial Folds, Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.
- to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
- to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
- to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
- to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported
- to evaluate all adverse events during the course of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emervel Classic | Experimental | Device: Emervel ClassicSubjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling. |
| Emervel Deep | Experimental | Device: Emervel DeepSubjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male or female subjects, 35 to 60 years of age
- Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator
- Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
- Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1).
- If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows:
Key exclusion criteria (19 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 filler-type injectable product
- Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (12) months before treatment
- Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch, within six (6) months before treatment
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 ClassicSubjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3) | Device | Emervel Classic |
| Emervel DeepSubjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4). | Device | Emervel Deep |
Primary outcome
Subject-reported time of return to social engagement after initial treatment
Time frame: 30 days
Time of return to social engagement (in hours)
6 secondary outcomes
Change from baseline to post-treatment follow-up time points in subject reported GAIS
Time frame: up to 30 days
Subject satisfaction with treatment outcome of the nasolabial folds
Time frame: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS
Time frame: 30 days
Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS
Time frame: 30 days
Incidence rate of subjects with adverse events (AEs)
Time frame: 30 days
Incidence rate of subjects with injection-related adverse events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- 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.
Author Swift, MD principal investigator
Arthur Swift Research Inc
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 Emervel Classic and Emervel Deep in people with Nasolabial Folds and Wrinkles, run by Galderma R&D 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 12 inclusion and 19 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 29 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject-reported time of return to social engagement after initial treatment (time frame: 30 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 29 Jul 2022.