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

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in Japan

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 Overview

• Status: Completed
• Conditions: Forehead Lines
• Intervention / Treatment: Drug: Placebo; Drug: OnabotulinumtoxinA

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Saitama, Japan, 333-0055
    • Chiharu Dermatology Clinic Urawa /ID# 268497
  • Tokyo, Japan, 101-0021
    • Akihabara Skin Clinic /ID# 268441
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 732-0053
      • Hiroshima Station Clinic /ID# 268467
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 063-0812
      • Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 268496
    • Yokohama, Kanagawa, Japan, 220-6208
      • Queens Square Medical Center, Dermatology and Allergology /ID# 268454
  • Nagano
    • Nagano, Nagano, Japan, 380-0826
      • Jun Clinic /ID# 268531
  • Okinawa
    • Naha, Okinawa, Japan, 900-0015
      • Touyama Plastic Surgery Clinic /ID# 268456
  • Osaka
    • Takatsuki, Osaka, Japan, 569-0824
      • Yoshikawa Skin Clinic /ID# 268494
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo Center Clinic /ID# 268477
    • Chuo-ku, Tokyo, Japan, 104-0061
      • Ginza Skin Clinic /ID# 268532
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Tokyo Asbo Clinic /ID# 268529
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital /ID# 268499
    • Nerima-ku, Tokyo, Japan, 177-0041
      • Forest Palace Dermatology Clinic /ID# 268599
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Greenwood Skin Clinic Tachikawa /ID# 268528

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.	Drug: OnabotulinumtoxinA; Intramuscular Injections
Experimental: Group 2; Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.	Drug: OnabotulinumtoxinA; Intramuscular Injections
Experimental: Group 3; Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.	Drug: Placebo; Intramuscular Injections; Drug: OnabotulinumtoxinA; Intramuscular Injections
Experimental: Group 4; Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.	Drug: Placebo; Intramuscular Injections; Drug: OnabotulinumtoxinA; Intramuscular Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity	The participant assesses FHL severity using the FWS-A scale ranging from none to severe.	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	The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.	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	For participants rated as at least mild at baseline, the investigator assesses FHL severity using the FWS-A scale ranging from none to severe.	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	The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.	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)	The FLSQ assesses treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ scale ranging from Very dissatisfied to Very satisfied.	Day 60
Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ	The FLSQ assesses treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ scale ranging from Very dissatisfied to Very satisfied.	Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale	The SKIN-Q Scale is a scale that measures the appearance of skin quality response option ranging from Very dissatisfied to Very satisfied.	Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit	The FACE-Q Psychological Function is a scale that measures psychological function with options ranging from definitely disagree to definitely agree.	Day 30

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Actual): April 3, 2026
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: OnabotulinumtoxinA; Forehead Lines; FHL Japan P3
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: M24-697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes