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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Eastern Plastic Surgery /ID# 244785
Box Hill North, Victoria, Australia
Dermatology Institute of Victoria /ID# 244786
South Yarra, Victoria, Australia
Complete Skin Specialists /ID# 244840
Sunbury, Victoria, Australia
SkinBox Clinics /ID# 244787
Fremantle, Australia
UZ Brussel /ID# 244761
Jette, Brussels Capital, Belgium
Centre de la fontaine /ID# 244763
Gerpinnes, Hainaut, Belgium
Plastische Chirurgie B V /ID# 253395
Oudenaarde, Oost-Vlaanderen, Belgium
Duinbergen Clinic /ID# 244765
Knokke-Heist, West-Vlaanderen, Belgium
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.
Time frame: Up to 90 Days
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Up to 90 Days
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