Local Tolerability After Lip Filler InjectionsNCT01745250
Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
A study testing Emervel Lips and Juvederm Ultra Smile in people with Local Tolerability After Lip Filler Injections, run by Galderma R&D at 1 site in Germany.
Trial summary
The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Local Tolerability After Lip Filler Injections
- What is being tested?
- Emervel Lips and Juvederm Ultra Smile
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Jul 2013
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects aged 18 to 65 years.
- Subjects with the intention to undergo lip augmentation treatment.
- Subjects treatment-naïve for lip augmentation treatment
- Subjects with lip appearance judged by the treating investigator to be suitable for lip line treatment
- 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.
- Previous tissue augmenting therapy in the lip area (including oral commissures, 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 area surrounding the lips (including nasolabial folds, oral commissures, marionette and perioral lines).
- 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.
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- 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.
- Previous hypersensitivity to HA.
- Previous hypersensitivity to lidocaine or other amide-type anaesthetics
- 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.
- 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, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result.
- Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile
- Being tested
- Emervel Lips, Juvederm Ultra Smile
- Keywords
- lip, fillers, Hyaluronic acid
- Medical subject headings
- Lymphoid Interstitial Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emervel LipsDevice
Lip treatment of both upper and lower lip
Juvederm Ultra SmileDevice
Lip treatment of both upper and lower lip
| Study group | Role | What they receive |
|---|---|---|
| Emervel Lips | Experimental | Emervel Lips Receives: Device: Emervel Lips |
| Juvederm Ultra Smile | Experimental | Juvederm Ultra Smile Receives: Device: Juvederm Ultra Smile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability
To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed.
Measured: 14 days
Secondary outcomes (4)
AE reporting
To evaluate long-term safety throughout the study period
Measured: 24 weeks
Global Aesthetic Improvement Scale (GAIS)
To evaluate esthetic change of lips from baseline using GEIS
Measured: Week 2 to week 24
Lip Fullness Grading Scale (LFGS)
To evaluate esthetic change of lips from baseline using LFGS
Measured: 0-24 weeks
Subject's satisfaction
To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Tolerability After 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Said Hilton, MD, Principal investigator, Medical Skin Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745250
- Sponsor's protocol ID
- 05DF1210
- Status last verified
- Jan 2016
- First submitted
- 4 Dec 2012
- 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 Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile
- ClinicalTrials.gov ID
- NCT01745250
- Acronym / sponsor ID
- 05DF1210
- Keywords
- lip, fillers, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Dec 2012 (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 demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emervel Lips | Experimental | Device: Emervel LipsEmervel Lips |
| Juvederm Ultra Smile | Experimental | Device: Juvederm Ultra SmileJuvederm Ultra Smile |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female subjects aged 18 to 65 years.
- Subjects with the intention to undergo lip augmentation treatment.
- Subjects treatment-naïve for lip augmentation treatment
- Subjects with lip appearance judged by the treating investigator to be suitable for lip line treatment
- Subjects with signed informed consent.
Key exclusion criteria (16 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.
- Previous tissue augmenting therapy in the lip area (including oral commissures, 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 area surrounding the lips (including nasolabial folds, oral commissures, 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 LipsLip treatment of both upper and lower lip | Device | Emervel Lips |
| Juvederm Ultra SmileLip treatment of both upper and lower lip | Device | Juvederm Ultra Smile |
Primary outcome
Local tolerability
Time frame: 14 days
To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed.
4 secondary outcomes
AE reporting
Time frame: 24 weeks
Global Aesthetic Improvement Scale (GAIS)
Time frame: Week 2 to week 24
Lip Fullness Grading Scale (LFGS)
Time frame: 0-24 weeks
Subject's satisfaction
Time frame: 0-24 weeks
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.
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.
Said Hilton, MD principal investigator
Medical Skin Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emervel Lips and Juvederm Ultra Smile in people with Local Tolerability After Lip Filler Injections, run by Galderma R&D at 1 site 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 5 inclusion and 16 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 1 site 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.
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?
Local tolerability (time frame: 14 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 25 Aug 2022.