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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05647551




Registration number
NCT05647551
Ethics application status
Date submitted
9/12/2022
Date registered
12/12/2022
Date last updated
23/10/2023

Titles & IDs
Public title
A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections
Scientific 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®
Secondary ID [1] 0 0
2022-000417-13
Secondary ID [2] 0 0
M22-979
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Facial Corrections 0 0
Facial Lines 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BOTOX®/VISTABEL®
Treatment: Devices - Juvéderm® VOLBELLA® with Lidocaine
Treatment: Devices - Juvéderm® VOLIFT® with Lidocaine
Treatment: Devices - Juvéderm® VOLUMA® with Lidocaine

Experimental: JUVÉDERM fillers and BOTOX/VISTABEL - 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.


Treatment: Drugs: BOTOX®/VISTABEL®
Facial Injection

Treatment: Devices: Juvéderm® VOLBELLA® with Lidocaine
Facial Injection

Treatment: Devices: Juvéderm® VOLIFT® with Lidocaine
Facial Injection

Treatment: Devices: Juvéderm® VOLUMA® with Lidocaine
Facial Injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the overall score of the participant's FACE-Q™ Satisfaction with Eyes with JUVÉDERM fillers and BOTOX/VISTABEL
Timepoint [1] 0 0
Up to 90 Days
Secondary outcome [1] 0 0
Percentage of Participants Achieving "Responder" status based on participant's assessment of GAIS of periorbital area
Timepoint [1] 0 0
At Day 90
Secondary outcome [2] 0 0
Percentage of Participant Achieving "Responder" status based on investigator's assessment of GAIS of periorbital area
Timepoint [2] 0 0
at Day 90
Secondary outcome [3] 0 0
Percentage of Participants Achieving "Responder" status based on investigator's assessment of global aesthetic improvement scale (GAIS) of infraorbital area
Timepoint [3] 0 0
At Day 30
Secondary outcome [4] 0 0
Change from baseline in overall score of the participant's assessment of FACE-Q Psychological Function
Timepoint [4] 0 0
Up to 90 Days

Eligibility
Key inclusion criteria
- 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).
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/10/2023
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Eastern Plastic Surgery /ID# 244785 - Box Hill North
Recruitment hospital [2] 0 0
Dermatology Institute of Victoria /ID# 244786 - South Yarra
Recruitment hospital [3] 0 0
Complete Skin Specialists /ID# 244840 - Sunbury
Recruitment hospital [4] 0 0
SkinBox Clinics /ID# 244787 - Fremantle
Recruitment postcode(s) [1] 0 0
3129 - Box Hill North
Recruitment postcode(s) [2] 0 0
3141 - South Yarra
Recruitment postcode(s) [3] 0 0
3429 - Sunbury
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles-Capitale
Country [2] 0 0
Belgium
State/province [2] 0 0
Hainaut
Country [3] 0 0
Belgium
State/province [3] 0 0
Oost-Vlaanderen
Country [4] 0 0
Belgium
State/province [4] 0 0
West-Vlaanderen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05647551
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries