Lip EnhancementNCT01176773
Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
A study testing hyaluronic acid gel in people with Lip Enhancement, run by Allergan Medical at 4 sites in United Kingdom.
Trial summary
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Enhancement
- What is being tested?
- hyaluronic acid gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Aug 2010to Jan 2012
- 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
- 18 years of age or older
- Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated
- Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked)
- Have established a realistic Lip Fullness treatment goal that 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 Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
- Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
- Are pregnant, lactating, or planning to become pregnant at any time during the study
- Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study
- Have a condition or be in a situation that, in the Investigator'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
Show all 9Show fewer
- Have a history of or currently suffer from autoimmune disease
- Have a history of treatment with interferon for chronic hepatitis C
- Be on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or have taken NSAIDs (e.g. aspirin, ibuprofen) or other substances known to increase coagulation time (e.g. herbal supplements with garlic or Gingko Biloba) within 10 days of undergoing study device injection. Note: Study device injection may be delayed as necessary to accommodate this 10-day wash out period
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Study site
Belfast
Study site
Cheadle
Study site
Halesowen
Study site
Sutton Coldfield
About this study
The purpose of this study is to demonstrate the safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
- Conditions
- Lip Enhancement
- Being tested
- hyaluronic acid gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic acid gelDevice
Dosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Experimental | Not described Receives: Device: hyaluronic acid gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment
Measured: 3 months
Secondary outcomes (5)
Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale
Score on 4-point Perioral Line Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.
Measured: 12 months
Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale
Score on 4-point Oral Commissures Severity Scale, where 0 is none and 3 is severe. A decreased score indicates improvement.
Measured: 12 months
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale
The scale consists of subcategories pertaining to how the subjects perceived aspects of their lips (e.g., softness, smoothness, etc). The outcome measure is the percentage of subjects who scored 0-3 on an 11-point scale, where a lower score on the scale indicates a positive result.
Measured: 3 months
Number of Subjects Who Attain Their Lip Treatment Goal
Prior to treatment and in consultation with the Investigator, the subject establishes a realistic lip fullness treatment goal. At follow-up, attainment is assessed as yes or no. The outcome measure is the percentage of subjects responding "yes" as to whether their pre-established lip fullness treatment goal had been attained.
Measured: 1-12 months
Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionJan 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 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT01176773
- Sponsor's protocol ID
- S15-002
- Status last verified
- Dec 2013
- First submitted
- 23 Mar 2010
- Last updated
- 13 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Eccleston D, Murphy DK. Juvederm((R)) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol. 2012;5:167-72. doi: 10.2147/CCID.S35800. Epub 2012 Oct 26.
PubMed 23152693
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
- Safety and Effectiveness of Juvéderm® Ultra Lip Injectable Gel for Lip Enhancement
- ClinicalTrials.gov ID
- NCT01176773
- Acronym / sponsor ID
- S15-002
- Conditions
- Lip Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Allergan MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 12 Jul 2012
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 safety and effectiveness of Juvéderm® Ultra Lip Injectable Gel for lip enhancement.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® Ultra Lip Injectable Gel | Experimental | Device: hyaluronic acid gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Desire enhancement of his/her vermilion borders and/or vermilion mucosa Cupid's bow, philtral columns, perioral lines, and oral commissures may also be treated
- Have a baseline score of Minimal of Mild, as assessed by the Investigator according to the 4-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked)
- Have established a realistic Lip Fullness treatment goal that Investigator agrees is achievable
Key exclusion criteria (9 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 Hyaluronic Acid fillers and/or collage is allowed, provided the treatment was administered not less than 6 months prior to study entry
- Have ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, L-polylactic acid, PMMA, silicone, ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study
- Have a history of anaphylaxis, multiple severe allergies, atopy, allergy to local anaesthesia agents, hyaluronic acid products or Streptococcal protein, or be planning to undergo desensitization therapy during the term of the study
- Are pregnant, lactating, or planning to become pregnant at any time during the study
- Have received investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this 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 |
|---|---|---|
| hyaluronic acid gelDosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL | Device | Juvéderm® Ultra Lip Injectable Gel |
Primary outcome
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale
Time frame: 3 months
The responder rate at 3 months, where a responder was defined as an improvement (increase) on the Lip Fullness Scale of ≥ 1 grade compared with the baseline assessment
5 secondary outcomes
Investigator Assessment of Perioral Line Severity Using the Perioral Line Severity Scale
Time frame: 12 months
Investigator Assessment of Oral Commissures Using the Oral Commissures Severity Scale
Time frame: 12 months
Subject Assessment of Appearance and Feel of the Lips Using the Look and Feel Scale
Time frame: 3 months
Number of Subjects Who Attain Their Lip Treatment Goal
Time frame: 1-12 months
Adverse Events
Time frame: 12 months
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.
- Background: PubMed 23152693Eccleston D, Murphy DK. Juvederm((R)) Volbella in the perioral area: a 12-month prospective, multicenter, open-label study. Clin Cosmet Investig Dermatol. 2012;5:167-72. doi: 10.2147/CCID.S35800. Epub 2012 Oct 26.
Related trials for Lip 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
Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyaluronic acid gel in people with Lip Enhancement, run by Allergan Medical at 4 sites in United Kingdom.
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 9 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 4 sites in 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 12 Jul 2012). 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?
Investigator Assessment of the Subject's Overall Lip Fullness on the 4-point Lip Fullness Scale (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 NCT01176773, 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.