CompletedPhase 4

A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections

Australia, Belgium73 participantsStarted 2023-01-05

Plain-language 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.

Who can participate

Age range40 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

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

Trial details

NCT IDNCT05647551

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-05