A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Forehead Lines in Chinese Adult Participants

Study Identifier
M22-043
CT.gov Identifier
NCT06174688
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English, Chinese (China)
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Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • BOTOX
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles. * Participant must have symmetrical FHL of moderate or severe rating at maximum contraction as assessed by both investigator and participant using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. * Participant must have glabellar lines (GL) severity of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
    Exclusion Criteria:
    * Participants with history of known immunization or hypersensitivity to any botulinum toxin serotype. * Participants with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class. * Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed. * Participant with history of treatments to the mid- or upper face.

    Protocol Summary

    Facial lines (such as glabellar lines \[GL\], lateral canthal lines \[LCL\], and forehead lines \[FHL\]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to assess adverse events and effectiveness of BOTOX in Chinese adults with moderate to severe FHL.

    Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study.

    Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at the study site. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Beijing Hospital /ID# 250059
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    Peking University First Hospital /ID# 249912
    Xicheng District, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    Guangdong Second Provincial General Hospital /ID# 250742
    Guangzhou, Guangdong, China, 510310
    Status
    Not applicable
    Location
    The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148
    Guangzhou, Guangdong, China, 510630
    Status
    Not applicable
    Location
    Peking university shenzhen hospital /ID# 249913
    Shenzhen, Guangdong, China, 518036
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 250022
    Wuhan, Hubei, China, 430022
    Status
    Not applicable
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