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

NCT05647551 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

  • Facial Corrections
  • Facial Lines

Interventions

DRUG

BOTOX®/VISTABEL®

Facial Injection

DEVICE

Juvéderm® VOLBELLA® with Lidocaine

Facial Injection

DEVICE

Juvéderm® VOLIFT® with Lidocaine

Facial Injection

DEVICE

Juvéderm® VOLUMA® with Lidocaine

Facial Injection

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2023-10-05
Completion
2023-10-05

Countries

  • Australia
  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647551 on ClinicalTrials.gov