A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

Completed · Phase 4

Conditions studied: Upper Facial Lines

In brief

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.

Key facts

Study ID

NCT06218251

Run by

AbbVie

People needed

100

Starts

2024-02-05

Expected to finish

2024-12-17

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe Glabellar Lines, Lateral Canthal Lines, and Forehead Lines.
• Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.

You may not qualify if…

• Presence or history of any medical condition that may place the participant at increased risk to BOTOX Cosmetic or interfere with the study evaluation.
• Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
• History of known immunization or hypersensitivity to any botulinum toxin serotype.

Where it is running

• Skin Wellness Dermatology - Homewood /ID# 248469 — Birmingham, Alabama, United States
• The Research Center at The Maas Clinic /ID# 256633 — San Francisco, California, United States
• Pacific Clinical Innovations /ID# 248467 — Vista, California, United States
• Kavali Plastic Surgery and Skin Renewal Center /ID# 248472 — Atlanta, Georgia, United States
• Tennessee Clinical Research Center /ID# 259161 — Nashville, Tennessee, United States
• Integrated Aesthetics - Spring /ID# 257738 — Spring, Texas, United States
• SkinDC /ID# 248470 — Arlington, Virginia, United States
• Skin Matters Medical Aesthetic Centre /ID# 249539 — Vancouver, British Columbia, Canada
• Project Skin MD - Ottawa /ID# 249718 — Ottawa, Ontario, Canada
• Bertucci MedSpa Inc. /ID# 249757 — Woodbridge, Ontario, Canada

Full record on ClinicalTrials.gov

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