Marionette Lines Forehead ContouringPhase 4VFORMNCT05077488
VFORM: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines
A Phase 4 study testing Juvéderm® VOLIFT™ with Lidocaine in people with Marionette Lines Forehead Contouring, run by Allergan at 1 site in France.
Trial summary
To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications: 1. Marionette lines (treatment skin depressions) 2. Forehead contouring (face contouring) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marionette Lines Forehead Contouring
- What is being tested?
- Juvéderm® VOLIFT™ with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 8 Nov 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older.
- Signed the Independent Ethics Committee (IEC)-approved informed consent form prior to any studyrelated procedures being performed.
- Eligible for treatment in at least one of the following treatment areas:
- Juvéderm VOLIFT treatment of skin depressions in the marionette lines:
- Grade 1, 2, 3 or 4 on both sides at baseline in the Allergan Marionette Line Scale
- Juvéderm VOLIFT is permitted in the oral commissures, at the discretion of the subject and investigator
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- Juvéderm VOLIFT treatment for irregularities of forehead contouring as assessed by the investigator and is likely to see improvement
- Accept the obligation not to receive any other facial procedures or treatments anywhere in the face during the study that are not related to the study.
- Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study.
- Ability to follow study instructions and likely to complete all required visits and assessments, as assessed by the Investigator.
- Affiliated to a health social security system.
Who cannot join
- In terms of population
- Females who are pregnant, nursing, or planning a pregnancy.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment (socially or mentally vulnerable).
- Current enrolment in an investigational drug or device study, participation in such a study within 6 weeks before enrollment, or be planning to participate in another investigation during the course of this study.
- Is an employee (or immediate relative of an employee) of the Investigator, study staff, Allergan, or a representative of Allergan.
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- In France: subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
- In terms of associated pathology
- Has a history of multiple or severe allergies, anaphylaxis, atopy, or allergy to lidocaine, HA products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
- Has an active inflammation or infection (acne, herpes,…), cancerous or precancerous lesion, or unhealed wound.
- Subject with history of hypertrophic scarring
- Has porphyria.
- Has epilepsy.
- Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction.
- History of, or currently suffering from, autoimmune disease or autoimmune deficiency or being under immunosuppressive therapy.
- History of streptococcal disease (recurrent sore throats, acute rheumatic fever).
- Has any uncontrolled disease.
- Has any condition or is 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. Relating to previous or ongoing treatment
- Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, threads) anywhere in the face, or is planning to be implanted with any of these products during the study.
- Has undergone semi-permanent dermal filler treatment (e.g., hyaluronic acid, calcium hydroxyapatite, poly-L-lactic acid) in the face within 12 months before enrolment or is planning to undergo such treatment during the study.
- Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the face within 6 months before enrolment or is planning to undergo any of these procedures during the study.
- Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle products within 90 days before enrolment or is planning to begin using such products during the study (subjects who have been on a regimen of such products for at least 90 days are eligible for the study if they intend to continue their regimen throughout the study).
- Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal antiinflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device treatment (study treatment may be delayed as necessary to accommodate this 10- day washout period).
- Is on a concurrent regimen of lidocaine or structurally related local anaesthetics (e.g., bupivacaine).
- Is on an ongoing treatment that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines
To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications:
- Marionette lines (treatment skin depressions)
- Forehead contouring (face contouring)
- Conditions
- Marionette Lines Forehead Contouring
- Being tested
- Juvéderm® VOLIFT™ with Lidocaine
- Keywords
- skin depressions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm® VOLIFT™ with LidocaineDevice
Sterile gel in disposable syringe
| Study group | Role | What they receive |
|---|---|---|
| Juvéderm® VOLIFT™ with Lidocaine | Experimental | Intradermal injection (deep dermis) in marionettes lines and/or forehead by a specialist injector Receives: Device: Juvéderm® VOLIFT™ with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image.
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Measured: Baseline to 30 Days
Marionette Lines: Proportion of subjects with a ≥1-point change in the Marionette Line scale from baseline before treatment to 30 days post treatment.
The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines
Measured: Baseline to 30 Days
Secondary outcomes (12)
Forehead Contouring: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their facial appearance. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Measured: Baseline to 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a ≥1-point change in the Allergan Marionette Line scale from baseline before treatment to 3 months, 6 months, 9 months, 12 months
The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines
Measured: Baseline before treatment to 3 months, 6 months, 9 months, 12 months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor using a 3D image at 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Measured: 3 months, 6 months, 9 months and 12 months
Marionette Lines: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their facial appearance. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.
Measured: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Measured: 30 days to 12 Months
Marionette Lines: Change in overall FACE-Q Appraisal of lines: marionette score from baseline to all administered timepoints
The participant assessed appraisal of marionette lines using the FACE-Q questionnaire measured on a 4-point scale where 1=Not At All, 2=A Little, 3=Moderately , 4=Extremely. The responses to the items on the questionnaire are converted to a 100-point Rasch transformed scale score with 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Measured: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Measured: 30 days, 3 months, 6 months, 9 months and 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects marionette lines
Measured: 30 days, 3 months, 6 months, 9 months and 12 months
Forehead Contouring: Volume change in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Measured: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Volume change in the marionette lines using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Measured: 30 days, 3 months, 6 months, 9 months, 12 months
Forehead Contouring: Contour changes in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Measured: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects marionette lines
Measured: 30 days, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start15 Sep 2021
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marionette Lines Forehead ContouringStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077488
- Sponsor's protocol ID
- MED-MA-FAS-0651
- Other IDs
- 2021-A00606-35
- Acronym
- VFORM
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2021
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open Label, Study to Evaluate VOLIFT With Lidocaine Treatment for FORehead Contouring and Marionette Lines
- ClinicalTrials.gov ID
- NCT05077488
- Acronym / sponsor ID
- VFORM / MED-MA-FAS-0651
- Conditions
- Marionette Lines Forehead Contouring
- Keywords
- skin depressions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- 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.
To collect post-marketing data on Juvéderm® VOLIFT™ with Lidocaine on the following indications:
- Marionette lines (treatment skin depressions)
- Forehead contouring (face contouring)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Juvéderm® VOLIFT™ with Lidocaine | Experimental | Device: Juvéderm® VOLIFT™ with LidocaineIntradermal injection (deep dermis) in marionettes lines and/or forehead by a specialist injector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, 18 years of age or older.
- Signed the Independent Ethics Committee (IEC)-approved informed consent form prior to any studyrelated procedures being performed.
- Eligible for treatment in at least one of the following treatment areas:
- Accept the obligation not to receive any other facial procedures or treatments anywhere in the face during the study that are not related to the study.
- Women of childbearing potential must have a negative urine pregnancy test before each injectable treatment and practice a reliable method of contraception throughout the study.
Key exclusion criteria (25 listed)
- In terms of population
- Females who are pregnant, nursing, or planning a pregnancy.
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment (socially or mentally vulnerable).
- Current enrolment in an investigational drug or device study, participation in such a study within 6 weeks before 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 |
|---|---|---|
| Juvéderm® VOLIFT™ with LidocaineSterile gel in disposable syringe | Device | Juvéderm® VOLIFT™ with Lidocaine |
Primary outcome
Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image.
Time frame: Baseline to 30 Days
The Global Aesthetic Improvement Scale is a 5-point scale ranging from "Much Improved" to "Much Worse" and it is used for the assessment of the level of improvement to the subjects forehead contouring
Marionette Lines: Proportion of subjects with a ≥1-point change in the Marionette Line scale from baseline before treatment to 30 days post treatment.
Time frame: Baseline to 30 Days
The Marionette Line scale is a 5-point scale ranging from 0 (None- No Lines) to 4 (Very Severe) and it is used for the assessment of the level of improvement to the subjects marionette lines
12 secondary outcomes
Forehead Contouring: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: Baseline to 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a ≥1-point change in the Allergan Marionette Line scale from baseline before treatment to 3 months, 6 months, 9 months, 12 months
Time frame: Baseline before treatment to 3 months, 6 months, 9 months, 12 months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor using a 3D image at 3 months, 6 months, 9 months and 12 months
Time frame: 3 months, 6 months, 9 months and 12 months
Marionette Lines: Change in overall FACE-Q Satisfaction with Facial Appearance score from baseline to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
Time frame: 30 days to 12 Months
Marionette Lines: Change in overall FACE-Q Appraisal of lines: marionette score from baseline to all administered timepoints
Time frame: Baseline to 12 Months
Forehead Contouring: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the investigator using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months
Forehead Contouring: Volume change in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Volume change in the marionette lines using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Forehead Contouring: Contour changes in the forehead using 3D imaging from baseline before treatment to 30 days, 3 months, 6 months, 9 months, 12 months
Time frame: 30 days, 3 months, 6 months, 9 months, 12 months
Marionette Lines: Proportion of subjects with a GAIS equal to 'improved" or "much improved" as assessed by the subjects using baseline 2D photographs (live evaluation) at 30 days, 3 months, 6 months, 9 months and 12 months
Time frame: 30 days, 3 months, 6 months, 9 months and 12 months
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 30 Nov 2022.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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.
ALLERGAN INC. study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Juvéderm® VOLIFT™ with Lidocaine in people with Marionette Lines Forehead Contouring, run by Allergan at 1 site in France.
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 11 inclusion and 25 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 30 Nov 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Forehead Contouring: Proportion of subjects with a Global Aesthetic Improvement Scale (GAIS) equal to 'improved" or "much improved" as assessed by a blinded aesthetic doctor of the contouring of the forehead using a 3D image. (time frame: Baseline to 30 Days). 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?
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 30 Nov 2022.