A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants

Study Identifier
M24-697
CT.gov Identifier
NCT06794866
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Facial Aesthetics - Toxins
    • Study Drug
  • OnabotulinumtoxinA
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment. * Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment. * Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]).
    Exclusion Criteria:
    * FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment. * History of known immunization or hypersensitivity to any botulinum neurotoxin serotype. * History of treatments to the mid or upper face.

    Protocol Summary

    Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically 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 onabotulinumtoxinA in Japanese adults with moderate to severe FHL.

    Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan.

    In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months.

    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
    Hiroshima Station Clinic /ID# 268467
    Hiroshima, Hiroshima, Japan, 732-0053
    Status
    Not applicable
    Location
    Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460
    Sapporo, Hokkaido, Japan, 063-0812
    Status
    Not applicable
    Location
    Tokai University Hospital /ID# 268496
    Isehara, Kanagawa, Japan, 259-1193
    Status
    Not applicable
    Location
    Queens Square Medical Center, Dermatology and Allergology /ID# 268454
    Yokohama, Kanagawa, Japan, 220-6208
    Status
    Not applicable
    Location
    Jun Clinic /ID# 268531
    Nagano, Nagano, Japan, 380-0826
    Status
    Not applicable
    Location
    Touyama Plastic Surgery Clinic /ID# 268456
    Naha, Okinawa, Japan, 900-0015
    Status
    Not applicable
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