A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines
NCT ID: NCT06218251
Last Updated: 2025-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2024-02-05
2024-12-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BOTOX
Participants will receive injections in the glabellar complex, in each of the lateral canthal area, and in the frontalis muscle on Day 1.
BOTOX
Intramuscular Injections
Interventions
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BOTOX
Intramuscular Injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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M22-974
Identifier Type: -
Identifier Source: org_study_id
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