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

Phase 3

Active, not recruiting

• Conditions: Forehead Lines
• Interventions: Drug: OnabotulinumtoxinA; Drug: Placebo

• Registration Number: NCT06794866
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study Start: 2025-01-22
• Study First Posted: 2025-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-20
• Primary Completion: 2026-03
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	OnabotulinumtoxinA	Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.
Group 2	OnabotulinumtoxinA	Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.
Group 3	OnabotulinumtoxinA	Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
Group 3	Placebo	Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
Group 4	OnabotulinumtoxinA	Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.
Group 4	Placebo	Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.

Primary Outcome Measures

Name	Time	Method
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	Day 30	The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Number of Participants with Adverse Events (AEs)	Up to approximately 12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Tokai University Hospital /ID# 268496; 🇯🇵 Isehara, Kanagawa, Japan

Queen's Square Medical Center, Dermatology and Allergology /ID# 268454; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Jun Clinic /ID# 268531; 🇯🇵 Nagano-Shi, Nagano, Japan

Tokyo Center Clinic /ID# 268477; 🇯🇵 Chuo-ku, Tokyo, Japan

Touyama Plastic Surgery Clinic /ID# 268456; 🇯🇵 Naha-shi, Okinawa, Japan

Hiroshima Station Clinic /ID# 268467; 🇯🇵 Hiroshima-Shi, Hiroshima, Japan

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460; 🇯🇵 Sapporo, Hokkaido, Japan

Akihabara Skin Clinic /ID# 268441; 🇯🇵 Tokyo, Japan

Kitasato University Kitasato Institute Hospital /ID# 268499; 🇯🇵 Tokyo, Japan

Yoshikawa Skin Clinic /ID# 268494; 🇯🇵 Takatsuki, Osaka, Japan

Tokyo Asbo Clinic /ID# 268529; 🇯🇵 Central District, Tokyo, Japan

Ginza Skin Clinic /ID# 268532; 🇯🇵 Chuo-ku, Tokyo, Japan

Forest Palace Dermatology Clinic /ID# 268599; 🇯🇵 Nerima-ku, Tokyo, Japan

Greenwood skin clinic Tachikawa /ID# 268528; 🇯🇵 Tachikawa-shi, Tokyo, Japan

Chiharu Dermatology Clinic Urawa /ID# 268497; 🇯🇵 Saitama, Japan