Clinical trial NCT05647551: A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Facial Corrections
Facial Lines
Keywords: JUVÉDERM fillers
BOTOX/VISTABEL
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 73
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

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.

Primary outcomes:
measure: Change from baseline in the overall score of the participant's FACE-Q™ Satisfaction with Eyes with JUVÉDERM fillers and BOTOX/VISTABEL
timeFrame: Up to 90 Days
Secondary outcomes:
measure: Percentage of Participants Achieving "Responder" status based on participant's assessment of GAIS of periorbital area
timeFrame: At Day 90
measure: Percentage of Participant Achieving "Responder" status based on investigator's assessment of GAIS of periorbital area
timeFrame: at Day 90
measure: Percentage of Participants Achieving "Responder" status based on investigator's assessment of global aesthetic improvement scale (GAIS) of infraorbital area
timeFrame: At Day 30
measure: Change from baseline in overall score of the participant's assessment of FACE-Q Psychological Function
timeFrame: Up to 90 Days
Other outcomes:
Locations:
city: Box Hill North
country: Australia
facility: Eastern Plastic Surgery /ID# 244785
state: Victoria
city: South Yarra
country: Australia
facility: Dermatology Institute of Victoria /ID# 244786
state: Victoria
city: Sunbury
country: Australia
facility: Complete Skin Specialists /ID# 244840
state: Victoria
city: Fremantle
country: Australia
facility: SkinBox Clinics /ID# 244787
city: Jette
country: Belgium
facility: UZ Brussel /ID# 244761
state: Bruxelles-Capitale
city: Gerpinnes
country: Belgium
facility: Centre de la fontaine /ID# 244763
state: Hainaut
city: Oudenaarde
country: Belgium
facility: Plastische Chirurgie B V /ID# 253395
state: Oost-Vlaanderen
city: Knokke-Heist
country: Belgium
facility: Duinbergen Clinic /ID# 244765
state: West-Vlaanderen
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: