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

Study Identifier
M22-979
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch (Belgium)

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
  • Study Drug
  • BOTOX®/VISTABEL®
  • Phase
    Phase 4
    Sex
    Female & Male
    Age
    40 - 65 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Eastern Plastic Surgery /ID# 244785
    Box Hill North, Victoria, Australia, 3129
    Status
    Not applicable
    Location
    Dermatology Institute of Victoria /ID# 244786
    South Yarra, Victoria, Australia, 3141
    Status
    Not applicable
    Location
    Complete Skin Specialists /ID# 244840
    Sunbury, Victoria, Australia, 3429
    Status
    Not applicable
    Location
    SkinBox Clinics /ID# 244787
    Fremantle, Australia, 6160
    Status
    Not applicable
    Location
    UZ Brussel /ID# 244761
    Jette, Brussels Capital, Belgium, 1090
    Status
    Not applicable
    Location
    Centre de la fontaine /ID# 244763
    Gerpinnes, Hainaut, Belgium, 6280
    Status
    Not applicable
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