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 3Active Not RecruitingNCT06794866

AbbVie150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Forehead Lines

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (15)

Hiroshima Station Clinic /ID# 268467

Hiroshima, Hiroshima, Japan

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460

Sapporo, Hokkaido, Japan

Tokai University Hospital /ID# 268496

Isehara, Kanagawa, Japan

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

Yokohama, Kanagawa, Japan

Jun Clinic /ID# 268531

Nagano, Nagano, Japan

Touyama Plastic Surgery Clinic /ID# 268456

Naha, Okinawa, Japan

Yoshikawa Skin Clinic /ID# 268494

Takatsuki, Osaka, Japan

Tokyo Center Clinic /ID# 268477

Chuo-ku, Tokyo, Japan

Tokyo Asbo Clinic /ID# 268529

Chuo-ku, Tokyo, Japan

Ginza Skin Clinic /ID# 268532

Chuo-ku, Tokyo, Japan

...and 5 more locations

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to approximately 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 30