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

Study Identifier
M22-974
CT.gov Identifier
NCT06218251
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Plain Language Summary
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
  • BOTOX
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Skin Wellness Dermatology - Homewood /ID# 248469
    Birmingham, Alabama, United States, 35209-8314
    Status
    Not applicable
    Location
    The Research Center at The Maas Clinic /ID# 256633
    San Francisco, California, United States, 94115-1809
    Status
    Not applicable
    Location
    Pacific Clinical Innovations /ID# 248467
    Vista, California, United States, 92083-6030
    Status
    Not applicable
    Location
    Kavali Plastic Surgery and Skin Renewal Center /ID# 248472
    Atlanta, Georgia, United States, 30328
    Status
    Not applicable
    Location
    Tennessee Clinical Research Center /ID# 259161
    Nashville, Tennessee, United States, 37215-2885
    Status
    Not applicable
    Location
    Integrated Aesthetics - Spring /ID# 257738
    Spring, Texas, United States, 77388
    Status
    Not applicable
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