Lip Volume EnhancementNCT01579305
Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
A study testing Juvéderm® Volbella with Lidocaine and Restylane-L® in people with Lip Volume Enhancement, run by Allergan Medical at 2 sites in 2 countries.
Trial summary
The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L® Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Volume Enhancement
- What is being tested?
- Juvéderm® Volbella with Lidocaine and Restylane-L®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2012to Jan 2014
- Phase
- Interventional
- 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
Who may be able to join
- Desire enhancement of his/her vermilion borders and/or vermilion mucosa
- Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)
- Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable
Who cannot join
- Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
- Conditions
- Lip Volume Enhancement
- Being tested
- Juvéderm® Volbella with Lidocaine, Restylane-L®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm® Volbella with LidocaineDevice
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
Restylane-L®Device
Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® Volbella with Lidocaine | Experimental | Subjects injected with Juvéderm® Volbella with Lidocaine in their lips Receives: Device: Juvéderm® Volbella with Lidocaine |
| Restylane-L® | Active comparator | Subjects injected with Restylane-L® in their lips Receives: Device: Restylane-L® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJan 2014
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 Volume EnhancementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579305
- Sponsor's protocol ID
- S15L-003
- Status last verified
- Jan 2019
- First submitted
- 16 Apr 2012
- Last updated
- 17 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.
PubMed 25878932
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
- ClinicalTrials.gov ID
- NCT01579305
- Acronym / sponsor ID
- S15L-003
- Conditions
- Lip Volume Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Posted 5 Aug 2014
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 evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® Volbella with Lidocaine | Experimental | Device: Juvéderm® Volbella with LidocaineSubjects injected with Juvéderm® Volbella with Lidocaine in their lips |
| Restylane-L® | Active comparator | Device: Restylane-L®Subjects injected with Restylane-L® in their lips |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Desire enhancement of his/her vermilion borders and/or vermilion mucosa
- Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)
- Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable
Key exclusion criteria (2 listed)
- Have undergone cosmetic facial, lip or perioral procedures [e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during 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 |
|---|---|---|
| Juvéderm® Volbella with LidocaineUp to 4.0 mL at the discretion of the Investigator to achieve optimal results | Device | Juvéderm® Volbella with Lidocaine |
| Restylane-L®Up to 4.0 mL at the discretion of the Investigator to achieve optimal results | Device | Restylane-L® |
Primary outcome
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
Time frame: 3 months
The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25878932Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.
Related trials for Lip Volume Enhancement
Recruiting
THE EVALUATION OF THE SAFETY AND PERFORMANCE OF AN INJECTABLE HYALURONIC ACID FILLER
Lips Enhancement Nasolabial Fold Correction Midface Volume Deficit
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
RecruitingObservational study
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Perioral Wrinkles, Crow's Feet
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Juvéderm® Volbella with Lidocaine and Restylane-L® in people with Lip Volume Enhancement, run by Allergan Medical at 2 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 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 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, United Kingdom. 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 5 Aug 2014). 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?
Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment (time frame: 3 months). 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 NCT01579305, 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 17 Jan 2019.