Wrinkles and Folds in Lower FacePhase 4NCT02573337
Perception of Facial Expressions Following Correction of Wrinkles and Folds
A Phase 4 study testing Emervel Classic Lidocaine and Emervel Deep Lidocaine in people with Wrinkles and Folds in Lower Face, run by Galderma R&D at 3 sites in Germany.
Trial summary
The purpose of this study is 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles and Folds in Lower Face
- What is being tested?
- Emervel Classic Lidocaine and Emervel Deep Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2015to Jan 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- NLFs assessed as moderate of severe using the WSRS
- Intent to undergo optimal correction of both NLFs
- Intent to undergo correction of at least one other wrinkle or fold in the lower face
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
- Subject who presents with severe midface volume loss
- Subject who presents with facial hair, e.g. beard, moustache, in the treatment area
- Woman who is pregnant or breast feeding or plans to become pregnant during the study
- 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
- Previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
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- Previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch
- Previous tissue augmenting therapy, contouring or revitalisation treatment with non-HA filler, e.g. Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), below the zygomatic arch within 24 months before treatment
- Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 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
- 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)
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Multi-center, Non-comparative 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
The purpose of this study is 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.
- Conditions
- Wrinkles and Folds in Lower Face
- Being tested
- Emervel Classic Lidocaine, Emervel Deep Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel Classic LidocaineDevice
Treatment of wrinkles and folds
Emervel Deep LidocaineDevice
Treatment of wrinkles and folds
| Study group | Role | What they receive |
|---|---|---|
| Intradermal injection | Experimental | Emervel Classic Lidocaine and/or Emervel Deep Lidocaine Receives: Device: Emervel Classic Lidocaine; Device: Emervel Deep Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment impact on facial expressions
Perception of naturalness
Measured: 1 month after touch-up treatment
Secondary outcomes (6)
Safety by assessment of local tolerability
Measured: 2 weeks after first treatment
Safety by assessment of Adverse Events
Measured: 0-13 months
Treating investigator satisfaction with treatment outcome
Questionnaire
Measured: 1 month after touch-up
Subject satisfaction with treatment outcome
Questionnaires
Measured: 1 month after touch-up
Nasolabial fold severity
WSRS photo scale
Measured: Before treatment and 2 weeks after first treatment and 1 month after touch-up
Aesthetic improvement of lower face
GAIS
Measured: 1 month after touch-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles and Folds in Lower FaceStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573337
- Sponsor's protocol ID
- 05DF1502
- Status last verified
- Jan 2016
- First submitted
- 8 Oct 2015
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-comparative 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
- NCT02573337
- Acronym / sponsor ID
- 05DF1502
- Conditions
- Wrinkles and Folds in Lower Face
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Oct 2015 (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.
The purpose of this study is 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradermal injection | Experimental | Device: Emervel Classic Lidocaine, Device: Emervel Deep LidocaineEmervel Classic Lidocaine and/or Emervel Deep Lidocaine |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- NLFs assessed as moderate of severe using the WSRS
- Intent to undergo optimal correction of both NLFs
- Intent to undergo correction of at least one other wrinkle or fold in the lower face
Key exclusion criteria (12 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
- Subject who presents with severe midface volume loss
- Subject who presents with facial hair, e.g. beard, moustache, in the treatment area
- Woman who is pregnant or breast feeding or plans to become pregnant during the study
- 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
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 LidocaineTreatment of wrinkles and folds | Device | Intradermal injection |
| Emervel Deep LidocaineTreatment of wrinkles and folds | Device | Intradermal injection |
Primary outcome
Treatment impact on facial expressions
Time frame: 1 month after touch-up treatment
Perception of naturalness
6 secondary outcomes
Safety by assessment of local tolerability
Time frame: 2 weeks after first treatment
Safety by assessment of Adverse Events
Time frame: 0-13 months
Treating investigator satisfaction with treatment outcome
Time frame: 1 month after touch-up
Subject satisfaction with treatment outcome
Time frame: 1 month after touch-up
Nasolabial fold severity
Time frame: Before treatment and 2 weeks after first treatment and 1 month after touch-up
Aesthetic improvement of lower face
Time frame: 1 month after touch-up
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 25 Aug 2022.
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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.
3 sites 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 Lidocaine and Emervel Deep Lidocaine in people with Wrinkles and Folds in Lower Face, run by Galderma R&D at 3 sites in Germany.
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 4 inclusion and 12 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
Treatment impact on facial expressions (time frame: 1 month after touch-up treatment). 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 25 Aug 2022.