A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines (UFL BOND 974)

A Prospective, Multi-center, Open-label Study to Evaluate Subject Satisfaction and Natural Outcomes Following Administration of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Upper Facial Lines (Glabellar Lines, Lateral Canthal Lines, and Forehead Lines)

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.

Study Overview

• Status: Completed
• Conditions: Upper Facial Lines
• Intervention / Treatment: Drug: BOTOX

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6M 4J2
      • Skin Matters Medical Aesthetic Centre /ID# 249539
  • Ontario
    • Ottawa, Ontario, Canada, K1K 2Z7
      • Project Skin MD - Ottawa /ID# 249718
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci MedSpa Inc. /ID# 249757
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209-8314
      • Skin Wellness Dermatology - Homewood /ID# 248469
  • California
    • San Francisco, California, United States, 94115-1809
      • The Research Center at The Maas Clinic /ID# 256633
    • Vista, California, United States, 92083-6030
      • Pacific Clinical Innovations /ID# 248467
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Kavali Plastic Surgery and Skin Renewal Center /ID# 248472
  • Tennessee
    • Nashville, Tennessee, United States, 37215-2885
      • Tennessee Clinical Research Center /ID# 259161
  • Texas
    • Spring, Texas, United States, 77388
      • Integrated Aesthetics - Spring /ID# 257738
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC /ID# 248470

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOTOX; Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.	Drug: BOTOX; Intramuscular Injections; Other Names: OnabotulinumtoxinA; Botulinum Toxin Type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Responder Status of 'Mostly Satisfied' or 'Very Satisfied' on the Facial Line Satisfaction Questionnaire (FLSQ) Follow Up Item 4 (Satisfaction With the Natural Look)	The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with upper facial lines using the FLSQ 5-point scale where: -2=Very dissatisfied and 2=Very satisfied.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The responses score ranges from 0 to 100. Higher scores reflect a better outcome.	Day 30

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; Botulinum Toxin Type A; Glabellar Lines; BOTOX; Wrinkles; Lateral Canthal Lines; Facial Wrinkles; Forehead Lines; Upper Facial Lines; Crows Feet Lines; Facial Rhytides
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: M22-974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No