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

NCT06794866 | Completed Phase 3 FDA Drug

• 1 other identifier: M24-697
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Forehead Lines

Keywords

Forehead Lines; OnabotulinumtoxinA; FHL Japan P3

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction

  The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.

  Day 30

• Number of Participants with Adverse Events (AEs)

  Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 12 months

Secondary Outcomes (8)

• Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity

  Day 30

• Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction

  Day 30

• Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest

  Day 30

• Time to Return to at least 'Moderate' for the Participants who Achieve Investigator FWS-A ratings of 'None' or 'Mild' on FHL Severity at Maximum Contraction

  Day 30

• Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ)

  Day 60

Study Arms (4)

Group 1

EXPERIMENTAL

Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.

Drug: OnabotulinumtoxinA

Group 2

EXPERIMENTAL

Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.

Drug: OnabotulinumtoxinA

Group 3

EXPERIMENTAL

Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.

Drug: OnabotulinumtoxinA; Drug: Placebo

Group 4

EXPERIMENTAL

Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.

Drug: OnabotulinumtoxinA; Drug: Placebo

Interventions

OnabotulinumtoxinA DRUG

Intramuscular Injections

Group 1; Group 2; Group 3; Group 4

Placebo DRUG

Intramuscular Injections

Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[SARS-CoV-2\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

Hiroshima Station Clinic /ID# 268467

Hiroshima, Hiroshima, 732-0053, Japan

Location

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460

Sapporo, Hokkaido, 063-0812, Japan

Location

Tokai University Hospital /ID# 268496

Isehara, Kanagawa, 259-1193, Japan

Location

Queens Square Medical Center, Dermatology and Allergology /ID# 268454

Yokohama, Kanagawa, 220-6208, Japan

Location

Jun Clinic /ID# 268531

Nagano, Nagano, 380-0826, Japan

Location

Touyama Plastic Surgery Clinic /ID# 268456

Naha, Okinawa, 900-0015, Japan

Location

Yoshikawa Skin Clinic /ID# 268494

Takatsuki, Osaka, 569-0824, Japan

Location

Tokyo Center Clinic /ID# 268477

Chuo-ku, Tokyo, 103-0027, Japan

Location

Tokyo Asbo Clinic /ID# 268529

Chuo-ku, Tokyo, 104-0031, Japan

Location

Ginza Skin Clinic /ID# 268532

Chuo-ku, Tokyo, 104-0061, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 268499

Minato-ku, Tokyo, 108-8642, Japan

Location

Forest Palace Dermatology Clinic /ID# 268599

Nerima-ku, Tokyo, 177-0041, Japan

Location

Greenwood Skin Clinic Tachikawa /ID# 268528

Tachikawa-shi, Tokyo, 190-0023, Japan

Location

Chiharu Dermatology Clinic Urawa /ID# 268497

Saitama, 333-0055, Japan

Location

Akihabara Skin Clinic /ID# 268441

Tokyo, 101-0021, Japan

Location

Related Links

• Related Info

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: January 22, 2025
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (15)