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

Last updated: February 7, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

OnabotulinumtoxinA

Clinical Study ID

NCT06794866
M24-697
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessedby 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 assessedby investigator using the FWS-A at Day 1 prior to study treatment.

  • Good health as per the investigator's judgment based on medical history, abbreviatedphysical examination and vital sign measurements, including no known active pandemicinfection (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]).

Exclusion

Exclusion Criteria:

  • FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1prior to study treatment.

  • History of known immunization or hypersensitivity to any botulinum neurotoxinserotype.

  • History of treatments to the mid or upper face.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 22, 2025
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Hiroshima Station Clinic /ID# 268467

    Hiroshima-Shi, Hiroshima 732-0053
    Japan

    Active - Recruiting

  • Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460

    Sapporo, Hokkaido 063-0812
    Japan

    Active - Recruiting

  • Tokai University Hospital /ID# 268496

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Queen's Square Medical Center, Dermatology and Allergology /ID# 268454

    Yokohama-shi, Kanagawa 220-6208
    Japan

    Active - Recruiting

  • Jun Clinic /ID# 268531

    Nagano-Shi, Nagano 380-0826
    Japan

    Active - Recruiting

  • Touyama Plastic Surgery Clinic /ID# 268456

    Naha-shi, Okinawa 900-0015
    Japan

    Active - Recruiting

  • Yoshikawa Skin Clinic /ID# 268494

    Takatsuki, Osaka 569-0824
    Japan

    Active - Recruiting

  • Tokyo Asbo Clinic /ID# 268529

    Central District, Tokyo 1040031
    Japan

    Active - Recruiting

  • Ginza Skin Clinic /ID# 268532

    Chuo-ku, Tokyo 104-0061
    Japan

    Active - Recruiting

  • Tokyo Center Clinic /ID# 268477

    Chuo-ku, Tokyo 103-0027
    Japan

    Active - Recruiting

  • Forest Palace Dermatology Clinic /ID# 268599

    Nerima-ku, Tokyo 117-0041
    Japan

    Active - Recruiting

  • Greenwood skin clinic Tachikawa /ID# 268528

    Tachikawa-shi, Tokyo 190-0023
    Japan

    Active - Recruiting

  • Chiharu Dermatology Clinic Urawa /ID# 268497

    Saitama, 333-0055
    Japan

    Active - Recruiting

  • Akihabara Skin Clinic /ID# 268441

    Tokyo, 101-0021
    Japan

    Active - Recruiting

  • Kitasato University Kitasato Institute Hospital /ID# 268499

    Tokyo, 108-8642
    Japan

    Active - Recruiting

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