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

NCT06218251 | Completed Phase 4 Results FDA Drug

• 1 other identifier: M22-974
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Upper Facial Lines

Keywords

Glabellar Lines; Lateral Canthal Lines; Forehead Lines; BOTOX; Botulinum Toxin Type A; OnabotulinumtoxinA; Upper Facial Lines; Crows Feet Lines; Wrinkles; Facial Wrinkles; Facial Rhytides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Overall Score of the Participant's Assessment of FACE-Q Psychological Function

  Day 30

Study Arms (1)

BOTOX

EXPERIMENTAL

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

Interventions

BOTOX DRUG

Intramuscular Injections

Also known as: Botulinum Toxin Type A, OnabotulinumtoxinA

BOTOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

Skin Wellness Dermatology - Homewood /ID# 248469

Birmingham, Alabama, 35209-8314, United States

Location

The Research Center at The Maas Clinic /ID# 256633

San Francisco, California, 94115-1809, United States

Location

Pacific Clinical Innovations /ID# 248467

Vista, California, 92083-6030, United States

Location

Kavali Plastic Surgery and Skin Renewal Center /ID# 248472

Atlanta, Georgia, 30328, United States

Location

Tennessee Clinical Research Center /ID# 259161

Nashville, Tennessee, 37215-2885, United States

Location

Integrated Aesthetics - Spring /ID# 257738

Spring, Texas, 77388, United States

Location

SkinDC /ID# 248470

Arlington, Virginia, 22209, United States

Location

Skin Matters Medical Aesthetic Centre /ID# 249539

Vancouver, British Columbia, V6M 4J2, Canada

Location

Project Skin MD - Ottawa /ID# 249718

Ottawa, Ontario, K1K 2Z7, Canada

Location

Bertucci MedSpa Inc. /ID# 249757

Woodbridge, Ontario, L4L 8E2, Canada

Location

Related Links

• Related Info

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: AbbVie
• Organization: ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com

844-663-3742

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: February 5, 2024
• Primary Completion: July 25, 2024
• Study Completion: December 17, 2024
• Last Updated: November 24, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

US (7); CA (3)