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

Last updated: January 9, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

BOTOX

Clinical Study ID

NCT06218251
M22-974
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Presence or history of any medical condition that may place the participant atincreased risk to BOTOX Cosmetic or interfere with the study evaluation.

  • Presence of tattoos, jewelry, or clothing which obscures or interferes with thetarget area of interest and cannot be removed.

  • History of known immunization or hypersensitivity to any botulinum toxin serotype.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: BOTOX
Phase: 4
Study Start date:
February 05, 2024
Estimated Completion Date:
December 17, 2024

Connect with a study center

  • Skin Matters Medical Aesthetic Centre /ID# 249539

    Vancouver, British Columbia V6M 4J2
    Canada

    Site Not Available

  • Project Skin MD - Ottawa /ID# 249718

    Ottawa, Ontario K1K 2Z7
    Canada

    Site Not Available

  • Bertucci MedSpa Inc. /ID# 249757

    Woodbridge, Ontario L4L 8E2
    Canada

    Site Not Available

  • Skin Wellness Dermatology - Homewood /ID# 248469

    Birmingham, Alabama 35209-8314
    United States

    Site Not Available

  • The Research Center at The Maas Clinic /ID# 256633

    San Francisco, California 94115-1809
    United States

    Site Not Available

  • Pacific Clinical Innovations /ID# 248467

    Vista, California 92083-6030
    United States

    Site Not Available

  • Kavali Plastic Surgery and Skin Renewal Center /ID# 248472

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Tennessee Clinical Research Center /ID# 259161

    Nashville, Tennessee 37215-2885
    United States

    Site Not Available

  • Integrated Aesthetics - Spring /ID# 257738

    Spring, Texas 77388
    United States

    Site Not Available

  • SkinDC /ID# 248470

    Arlington, Virginia 22209
    United States

    Site Not Available

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