Facial CorrectionsPhase 4NCT05647551
A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections
A Phase 4 study testing BOTOX®/VISTABEL®, Juvéderm® VOLBELLA® with Lidocaine and Juvéderm® VOLIFT® with Lidocaine in people with Facial Corrections and Facial Lines, run by AbbVie at 8 sites in 2 countries.
Trial summary
Different studies have shown the negative effects of aging around the area of the eyes. Signs of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or sadness) that do not reflect the individual's true feelings affecting interpersonal relationships. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Facial Corrections, Facial Lines
- What is being tested?
- BOTOX®/VISTABEL®, Juvéderm® VOLBELLA® with Lidocaine and 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
- 73 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Jan 2023to 5 Oct 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant's dissatisfaction with eyes, measured by a baseline score of "very dissatisfied" or "somewhat dissatisfied" in at least 3 of the 7 items in the FACE-Q Satisfaction with Eyes.
- Have some degree of IOH/TT per Allergan Infraorbital Hollows Scale (AIHS) (1 [minimal], 2 [moderate], 3 [severe], or 4 [extreme]) on both sides with a chance of improvement either by direct or indirect treatment, per investigator's assessment.
- Need for treatment in at least 2 areas in the upper and/or mid face (e.g., eyebrows, IOH/TT, temples, malar or zygomatic, fine lines such as periorbital lines), with at least two of the JUVÉDERM products (Juvéderm VOLBELLA, Juvéderm VOLIFT, or Juvéderm VOLUMA), per investigator's assessment.
- Participant meets at least one of the following criteria (investigator's assessment):
- 2 or 3 (moderate or severe) on Allergan Glabellar Lines Severity Scale at maximum furrow.
- 2 or 3 (moderate or severe) on Lateral Canthal Lines Severity Scale at maximum smile.
- Participants must have a score of ≥ 5 for Facial Line Outcomes-11 item 1 (Bothered by Facial Lines).
Who cannot join
- Participants with presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated.
- Participant with an allergy or sensitivity to investigational products or their components.
- Participant with history or current symptoms of dysphagia.
- Participant has medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
- Participant has profound atrophy/excessive weakness of muscles in target areas of injection.
- Participant has marked facial asymmetry, brow or eyelid ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen the resting Glabellar Lines (GLs) and Lateral Canthal Lines (LCLs)/facial rhytides by physically spreading them apart.
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- Participant has tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads that would mask improvement.
- Participant has mid face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or human immunodeficiency virus-related disease.
- Participant has undergone live vaccination, surgery, or dental procedures (e.g., tooth extraction, orthodontia, or implantation) within 30 days prior to enrollment or be planning to undergo any of these procedures during the study and up to 30 days after the study.
- Participant has neuromuscular disorders including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise.
- Participant has received temporary or semi-permanent filler injections at upper or mid face (e.g., HA, calcium hydroxyapatite, L-polylactic acid) within 2 years prior to entry in the study.
- Participant has received any investigational product or device within 30 days or 5 half-lives of the drug (whichever is longer) prior to study enrollment or planning to participate in another investigation during the course of this study.
- Participant has undergone at anytime plastic surgery of the face, tissue grafting, or tissue augmentation with silicone, fat, or other permanent dermal fillers, or be planning to undergo any of these procedures at any time during the study.
- Participant has received mesotherapy, skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face within 6 months prior to study enrollment.
- Participant has a current use of nonsteroidal anti-inflammatory drug (e.g., aspirin, ibuprofen) with the exception of a daily low dose of aspirin, from 10 days prior to injection up to 3 days post-injection.
- Participant has had topical retinoid therapy and/or topical hormone cream applied to the face, for potential participants who have not been on a consistent dose regimen for at least 6 months prior to enrollment and who are unable to maintain regimen for the study.
- Participant has received systemic retinoid therapy within one year prior to study enrollment.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia4 sites
Eastern Plastic Surgery /ID# 244785
Box Hill North, Victoria, 3129
SkinBox Clinics /ID# 244787
Fremantle, 6160
Dermatology Institute of Victoria /ID# 244786
South Yarra, Victoria, 3141
Complete Skin Specialists /ID# 244840
Sunbury, Victoria, 3429
Belgium4 sites
Centre de la fontaine /ID# 244763
Gerpinnes, Hainaut, 6280
UZ Brussel /ID# 244761
Jette, Brussels Capital, 1090
Duinbergen Clinic /ID# 244765
Knokke-Heist, West-Vlaanderen, 8301
Plastische Chirurgie B V /ID# 253395
Oudenaarde, Oost-Vlaanderen, 9700
About this study
Official title: A Prospective, Open-Label Study to Evaluate Subject's Satisfaction With the Aesthetics of the Periorbital Area After Treatment of the Upper and/or Mid Face With JUVÉDERM® Fillers and BOTOX®/VISTABEL®
Different studies have shown the negative effects of aging around the area of the eyes. Signs of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or sadness) that do not reflect the individual's true feelings affecting interpersonal relationships. Minimally invasive aesthetic treatments with botulinum toxin and hyaluronic acid (HA) fillers are used to treat wrinkles and volume deficiencies associated with the appearance of most of the signs of aging.
This Phase 4 post-marketing study is an open-label study in which all subjects will receive active study treatment. The purpose of this study is to evaluate the subject's satisfaction after the treatment of JUVÉDERM® fillers and BOTOX®/VISTABEL® on the upper and/or mid face, which includes areas around the eyes, under the eyes, eyebrows, the temple, and the cheek.
Read more
This study will enroll approximately 80 healthy male and female subjects ages 40 to 65 across 10 sites in Australia, Belgium, and United Kingdom. Each subject will be in the study for approximately 90 days. The initial treatment of the JUVÉDERM fillers (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/ or Juvéderm VOLUMA with lidocaine) will be given on Visit 2, and if needed, a touch-up treatment will be given. On Visit 4, the Juvéderm VOLBELLA with lidocaine filler, may be given, followed by a touch-up treatment, if needed. On Visit 6, subjects will receive study drug BOTOX/VISTABEL. All subjects will return for the study exit visit on Day 90.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
- Conditions
- Facial Corrections, Facial Lines
- Being tested
- BOTOX®/VISTABEL®, Juvéderm® VOLBELLA® with Lidocaine, Juvéderm® VOLIFT® with Lidocaine, Juvéderm® VOLUMA® with Lidocaine
- Keywords
- JUVÉDERM fillers, BOTOX/VISTABEL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX®/VISTABEL®Drug
Facial Injection
Juvéderm® VOLBELLA® with LidocaineDevice
Facial Injection
Juvéderm® VOLIFT® with LidocaineDevice
Facial Injection
Juvéderm® VOLUMA® with LidocaineDevice
Facial Injection
| Study group | Role | What they receive |
|---|---|---|
| JUVÉDERM fillers and BOTOX/VISTABEL | Experimental | At Visit 1, JUVÉDERM filler injections (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/or Juvéderm VOLUMA with lidocaine) will be administered. At Visit 4, JUVÉDERM VOLBELLA with lidocaine, may be administered in the infraorbital hollow (IOH)/tear trough (TT) area. At Visit 6, participants will receive BOTOX/VISTABEL. Touch-ups may be performed as required based on investigator's assessment. Receives: Drug: BOTOX®/VISTABEL®; Device: Juvéderm® VOLBELLA® with Lidocaine; Device: Juvéderm® VOLIFT® with Lidocaine; Device: Juvéderm® VOLUMA® with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the overall score of the participant's FACE-Q™ Satisfaction with Eyes with JUVÉDERM fillers and BOTOX/VISTABEL
The FACE-Q Satisfaction with Eyes is a 7-item scale with a 4-point response options ranging from "very dissatisfied" to "very satisfied". The responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100. Higher scores indicate higher satisfaction.
Measured: Up to 90 Days
Secondary outcomes (4)
Percentage of Participants Achieving "Responder" status based on participant's assessment of GAIS of periorbital area
The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area.
Measured: At Day 90
Percentage of Participant Achieving "Responder" status based on investigator's assessment of GAIS of periorbital area
The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the periorbital area.
Measured: at Day 90
Percentage of Participants Achieving "Responder" status based on investigator's assessment of global aesthetic improvement scale (GAIS) of infraorbital area
The GAIS uses a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. A responder is defined as "improved" or "much improved" in the overall aesthetics assessment in the infraorbital area.
Measured: At Day 30
Change from baseline in overall score of the participant's assessment of FACE-Q Psychological Function
The FACE-Q Psychological Function is a 10-item scale that measures psychological function with a 4-point response options ranging from "definitely disagree" to "definitely agree". The responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100. Higher scores indicate higher satisfaction.
Measured: Up to 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start5 Jan 2023
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial CorrectionsStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647551
- Sponsor's protocol ID
- M22-979
- Other IDs
- 2022-000417-13
- Status last verified
- Oct 2024
- First submitted
- 9 Dec 2022
- Last updated
- 3 Oct 2024
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label Study to Evaluate Subject's Satisfaction With the Aesthetics of the Periorbital Area After Treatment of the Upper and/or Mid Face With JUVÉDERM® Fillers and BOTOX®/VISTABEL®
- ClinicalTrials.gov ID
- NCT05647551
- Acronym / sponsor ID
- M22-979
- Conditions
- Facial Corrections, Facial Lines
- Keywords
- JUVÉDERM fillers, BOTOX/VISTABEL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 12 Dec 2022 (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.
Different studies have shown the negative effects of aging around the area of the eyes. Signs of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or sadness) that do not reflect the individual's true feelings affecting interpersonal relationships. Minimally invasive aesthetic treatments with botulinum toxin and hyaluronic acid (HA) fillers are used to treat wrinkles and volume deficiencies associated with the appearance of most of the signs of aging.
This Phase 4 post-marketing study is an open-label study in which all subjects will receive active study treatment. The purpose of this study is to evaluate the subject's satisfaction after the treatment of JUVÉDERM® fillers and BOTOX®/VISTABEL® on the upper and/or mid face, which includes areas around the eyes, under the eyes, eyebrows, the temple, and the cheek.
This study will enroll approximately 80 healthy male and female subjects ages 40 to 65 across 10 sites in Australia, Belgium, and United Kingdom. Each subject will be in the study for approximately 90 days. The initial treatment of the JUVÉDERM fillers (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/ or Juvéderm VOLUMA with lidocaine) will be given on Visit 2, and if needed, a touch-up treatment will be given. On Visit 4, the Juvéderm VOLBELLA with lidocaine filler, may be given, followed by a touch-up treatment, if needed. On Visit 6, subjects will receive study drug BOTOX/VISTABEL. All subjects will return for the study exit visit on Day 90.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JUVÉDERM fillers and BOTOX/VISTABEL | Experimental | Drug: BOTOX®/VISTABEL®, Device: Juvéderm® VOLBELLA® with Lidocaine, Device: Juvéderm® VOLIFT® with Lidocaine, Device: Juvéderm® VOLUMA® with LidocaineAt Visit 1, JUVÉDERM filler injections (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/or Juvéderm VOLUMA with lidocaine) will be administered. At Visit 4, JUVÉDERM VOLBELLA with lidocaine, may be administered in the infraorbital hollow (IOH)/tear trough (TT) area. At Visit 6, participants will receive BOTOX/VISTABEL. Touch-ups may be performed as required based on investigator's assessment. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant's dissatisfaction with eyes, measured by a baseline score of "very dissatisfied" or "somewhat dissatisfied" in at least 3 of the 7 items in the FACE-Q Satisfaction with Eyes.
- Have some degree of IOH/TT per Allergan Infraorbital Hollows Scale (AIHS) (1 [minimal], 2 [moderate], 3 [severe], or 4 [extreme]) on both sides with a chance of improvement either by direct or indirect treatment, per investigator's assessment.
- Need for treatment in at least 2 areas in the upper and/or mid face (e.g., eyebrows, IOH/TT, temples, malar or zygomatic, fine lines such as periorbital lines), with at least two of the JUVÉDERM products (Juvéderm VOLBELLA, Juvéderm VOLIFT, or Juvéderm VOLUMA), per investigator's assessment.
- Participant meets at least one of the following criteria (investigator's assessment):
- Participants must have a score of ≥ 5 for Facial Line Outcomes-11 item 1 (Bothered by Facial Lines).
Key exclusion criteria (17 listed)
- Participants with presence of inflammation, infection at any injection site or systemic infection (study entry may be postponed until one week following recovery), noticeable acne scarring, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated.
- Participant with an allergy or sensitivity to investigational products or their components.
- Participant with history or current symptoms of dysphagia.
- Participant has medical condition that may increase the risk of exposure to botulinum toxin including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
- Participant has profound atrophy/excessive weakness of muscles in target areas of injection.
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 |
|---|---|---|
| BOTOX®/VISTABEL®Facial Injection | Drug | JUVÉDERM fillers and BOTOX/VISTABEL |
| Juvéderm® VOLBELLA® with LidocaineFacial Injection | Device | JUVÉDERM fillers and BOTOX/VISTABEL |
| Juvéderm® VOLIFT® with LidocaineFacial Injection | Device | JUVÉDERM fillers and BOTOX/VISTABEL |
| Juvéderm® VOLUMA® with LidocaineFacial Injection | Device | JUVÉDERM fillers and BOTOX/VISTABEL |
Primary outcome
Change from baseline in the overall score of the participant's FACE-Q™ Satisfaction with Eyes with JUVÉDERM fillers and BOTOX/VISTABEL
Time frame: Up to 90 Days
The FACE-Q Satisfaction with Eyes is a 7-item scale with a 4-point response options ranging from "very dissatisfied" to "very satisfied". The responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100. Higher scores indicate higher satisfaction.
4 secondary outcomes
Percentage of Participants Achieving "Responder" status based on participant's assessment of GAIS of periorbital area
Time frame: At Day 90
Percentage of Participant Achieving "Responder" status based on investigator's assessment of GAIS of periorbital area
Time frame: at Day 90
Percentage of Participants Achieving "Responder" status based on investigator's assessment of global aesthetic improvement scale (GAIS) of infraorbital area
Time frame: At Day 30
Change from baseline in overall score of the participant's assessment of FACE-Q Psychological Function
Time frame: Up to 90 Days
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 3 Oct 2024.
- 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.
ABBVIE INC. study director
AbbVie
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BOTOX®/VISTABEL®, Juvéderm® VOLBELLA® with Lidocaine and Juvéderm® VOLIFT® with Lidocaine in people with Facial Corrections and Facial Lines, run by AbbVie at 8 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 7 inclusion and 17 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Belgium. 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?
Change from baseline in the overall score of the participant's FACE-Q™ Satisfaction with Eyes with JUVÉDERM fillers and BOTOX/VISTABEL (time frame: Up to 90 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 3 Oct 2024.