Lip AugmentationNCT01629134
Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
An observational study of Lip Augmentation, run by Allergan Medical at 1 site in Germany.
Trial summary
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- Crosslinked hyaluronic acid gel
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers desiring lip augmentation
Who may be able to join
- Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
- Females and males ≥ 18 years of age
- Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results
Who cannot join
- Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
- Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
- Conditions
- Lip Augmentation
- Being tested
- Crosslinked hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosslinked hyaluronic acid gelDevice
Also called JUVÉDERM VOLBELLA™
All treatments are carried out according to the physician's experience and the Directions for Use
| Study group | Role | What they receive |
|---|---|---|
| Volbella | Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use Receives: Device: Crosslinked hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Rating of the Natural Look and Feel of the Lips
Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.
Measured: 4 weeks
Injector Rating of the Natural Look and Feel of the Lips
Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.
Measured: 4 weeks
Secondary outcomes (8)
Bruising of the Lips
Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips
Measured: 15 minutes after injection
Swelling of the Lips
Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips
Measured: 15 minutes after injection
Ease of Injection
Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)
Measured: 15 minutes after injection
Malleability of Product
Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)
Measured: 15 minutes after injection
Need for Massage
Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA
Measured: 15 minutes after injection
Return to Social Engagement
Time to return to normal daily activities
Measured: 4 weeks
Comparative Rating With Previous Treatment
Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse
Measured: 15 minutes after injection
Rating of Injection Discomfort
The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).
Measured: 15 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lip AugmentationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Allergan Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629134
- Sponsor's protocol ID
- MAF/AGN/MED/FIL/019
- Status last verified
- Oct 2014
- First submitted
- 25 Jun 2012
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085.
PubMed 24910276
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips
- ClinicalTrials.gov ID
- NCT01629134
- Acronym / sponsor ID
- MAF/AGN/MED/FIL/019
- Conditions
- Lip Augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Posted 14 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multicenter postmarket study of the use of JUVÉDERM VOLBELLA™ with Lidocaine in the lips.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volbella | – | Device: Crosslinked hyaluronic acid gelSubjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers desiring lip augmentation
Key inclusion criteria (3 listed)
- Desire and willingness for correction of asymmetry or volume enhancement of his/her lips
- Females and males ≥ 18 years of age
- Have established a realistic treatment goal that the Physician agrees is achievable, i.e., have realistic expectations of aesthetic results
Key exclusion criteria (2 listed)
- Not fulfilling the standard prescribing criteria for JUVÉDERM VOLBELLA™ with Lidocaine as detailed in the Directions for Use
- Have a condition or be in a situation that, in the Physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
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 |
|---|---|---|
| Crosslinked hyaluronic acid gelAlso: JUVÉDERM VOLBELLA™All treatments are carried out according to the physician's experience and the Directions for Use | Device | Volbella |
Primary outcome
Subject Rating of the Natural Look and Feel of the Lips
Time frame: 4 weeks
Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.
Injector Rating of the Natural Look and Feel of the Lips
Time frame: 4 weeks
Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.
8 secondary outcomes
Bruising of the Lips
Time frame: 15 minutes after injection
Swelling of the Lips
Time frame: 15 minutes after injection
Ease of Injection
Time frame: 15 minutes after injection
Malleability of Product
Time frame: 15 minutes after injection
Need for Massage
Time frame: 15 minutes after injection
Return to Social Engagement
Time frame: 4 weeks
Comparative Rating With Previous Treatment
Time frame: 15 minutes after injection
Rating of Injection Discomfort
Time frame: 15 minutes after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24910276Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014 Jun;13(2):125-34. doi: 10.1111/jocd.12085.
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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.
Medical Monitor study director
Allergan Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lip Augmentation, run by Allergan Medical 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 3 inclusion and 2 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 13 Oct 2014. 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?
Yes. Results are posted in the registry (first posted 14 May 2013). 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?
Subject Rating of the Natural Look and Feel of the Lips (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01629134, which also lists 1 linked publication.
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 13 Oct 2014.