Lip Filler InjectionsNCT01916278
Safety and Efficacy Study of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
A study testing Emervel Lips Lidocaine and Juvéderma Volbella with Lidocaine in people with Lip Filler Injections, run by Galderma R&D at 3 sites in 2 countries.
Trial summary
A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lip Filler Injections
- What is being tested?
- Emervel Lips Lidocaine and Juvéderma Volbella with Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2013to May 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and male subjects aged 18 to 65 years.
- Subjects with the intention to undergo lip augmentation treatment (vermilion mucosa and, if applicable, vermilion borders).
- Subjects with LFGS score of 0 (very thin), 1 (thin) and 2 (moderately thick) (scores may differ between upper and lower lip), and lip appearance judged by the treating investigator to be suitable for optimal correction (≥ 1 grade improvement on the LFGS per lip) with maximum 1.5 mL study product per lip.
- Subjects with signed informed consent.
Who cannot join
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
- Prior surgery or tattoo to the upper or lower lip or lip line.
- Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator. Tendency to form keloids, hypertrophic scars or any other healing disorders.
- Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, within 12 months before study entry.
- Permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines).
- Previous toxin treatment below the lower orbital rim within 9 months before study entry.
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- History of herpes labialis with an outbreak within 4 weeks of study entry or with 4 or more outbreaks in the 12 months before study entry.
- Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
- History of angioedema.
- Known hypersensitivity to HA, lidocaine or other amide-type anaesthetics or history of severe multiple allergies or anaphylactic shock
- Cancerous or precancerous lesions in the area to be treated.
- Immunosuppressive therapy, chemotherapy, treatment with biologics or systemic corticosteroids within 3 months before study treatment.
- Any medical condition that in the opinion of the investigator would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may affect the general condition or may require frequent medical treatment).
- Pregnancy or breast feeding.
- Participation in any other clinical study within 30 days before inclusion.
- Other condition preventing the subject to entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim and chin, subjects anticipated to be unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment result.
- Study site staff or close relatives to study site staff and employees at the sponsor company or close relatives to employees at the sponsor company. Close relatives are defined as parents, children, siblings and spouse.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Rosenpark Research
Darmstadt, 64283
Medical Skin Center
Düsseldorf
About this study
Official title: A Randomized, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.
- Conditions
- Lip Filler Injections
- Being tested
- Emervel Lips Lidocaine, Juvéderma Volbella with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel Lips LidocaineDevice
Juvéderma Volbella with LidocaineDevice
| Study group | Role | What they receive |
|---|---|---|
| Emervel Lips Lidocaine | Experimental | Not described Receives: Device: Emervel Lips Lidocaine |
| Juvéderm Volbella with Lidocaine | Experimental | Not described Receives: Device: Juvéderma Volbella with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lip Fullness Grading Scale (LFGS) score
To evaluate esthetic change of lips from baseline using LFGS
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip Filler InjectionsStudies 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
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916278
- Sponsor's protocol ID
- 05DF1215
- Status last verified
- Sep 2015
- First submitted
- 18 Jul 2013
- 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 Randomized, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips Lidocaine and Juvéderm Volbella With Lidocaine
- ClinicalTrials.gov ID
- NCT01916278
- Acronym / sponsor ID
- 05DF1215
- Conditions
- Lip Filler Injections
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Aug 2013 (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.
A 12-month, randomised, evaluator-blinded, comparative, multicentre study of the safety and efficacy of lip injections with Emervel Lips Lidocaine and Juvéderm Volbella with Lidocaine.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emervel Lips Lidocaine | Experimental | Device: Emervel Lips Lidocaine |
| Juvéderm Volbella with Lidocaine | Experimental | Device: Juvéderma Volbella with Lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male subjects aged 18 to 65 years.
- Subjects with the intention to undergo lip augmentation treatment (vermilion mucosa and, if applicable, vermilion borders).
- Subjects with LFGS score of 0 (very thin), 1 (thin) and 2 (moderately thick) (scores may differ between upper and lower lip), and lip appearance judged by the treating investigator to be suitable for optimal correction (≥ 1 grade improvement on the LFGS per lip) with maximum 1.5 mL study product per lip.
- Subjects with signed informed consent.
Key exclusion criteria (17 listed)
- Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders.
- Prior surgery or tattoo to the upper or lower lip or lip line.
- Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry, as judged by the investigator. Tendency to form keloids, hypertrophic scars or any other healing disorders.
- Previous tissue augmenting therapy in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines) with HA or collagen filler, or laser treatment, within 12 months before study entry.
- Permanent implant or treatment with non-HA or non-collagen filler in the lip area (including lips, oral commissures, nasolabial folds, marionette and perioral lines).
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 Lips Lidocaine | Device | Emervel Lips Lidocaine |
| Juvéderma Volbella with Lidocaine | Device | Juvéderm Volbella with Lidocaine |
Primary outcome
Lip Fullness Grading Scale (LFGS) score
Time frame: 0-12 months
To evaluate esthetic change of lips from baseline using LFGS
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emervel Lips Lidocaine and Juvéderma Volbella with Lidocaine in people with Lip Filler Injections, run by Galderma R&D at 3 sites in 2 countries.
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 17 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, Sweden. 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?
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?
Lip Fullness Grading Scale (LFGS) score (time frame: 0-12 months). 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.