Clinical trial NCT06794866: A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Forehead Lines
Keywords: Forehead Lines
OnabotulinumtoxinA
FHL Japan P3
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 30
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
timeFrame: Day 30
measure: 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
timeFrame: Day 30
measure: 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
timeFrame: Day 30
measure: 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
timeFrame: Day 30
measure: Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ)
timeFrame: Day 60
measure: Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ
timeFrame: Day 30
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale
timeFrame: Day 30
measure: Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
timeFrame: Day 30
Other outcomes:
Locations:
city: Hiroshima-Shi
country: Japan
facility: Hiroshima Station Clinic /ID# 268467
state: Hiroshima
city: Sapporo
country: Japan
facility: Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460
state: Hokkaido
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 268496
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Queen's Square Medical Center, Dermatology and Allergology /ID# 268454
state: Kanagawa
city: Nagano-Shi
country: Japan
facility: Jun Clinic /ID# 268531
state: Nagano
city: Naha-shi
country: Japan
facility: Touyama Plastic Surgery Clinic /ID# 268456
state: Okinawa
city: Takatsuki
country: Japan
facility: Yoshikawa Skin Clinic /ID# 268494
state: Osaka
city: Central District
country: Japan
facility: Tokyo Asbo Clinic /ID# 268529
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic /ID# 268477
state: Tokyo
city: Chuo-ku
country: Japan
facility: Ginza Skin Clinic /ID# 268532
state: Tokyo
city: Nerima-ku
country: Japan
facility: Forest Palace Dermatology Clinic /ID# 268599
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Greenwood skin clinic Tachikawa /ID# 268528
state: Tokyo
city: Saitama
country: Japan
facility: Chiharu Dermatology Clinic Urawa /ID# 268497
city: Tokyo
country: Japan
facility: Akihabara Skin Clinic /ID# 268441
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 268499
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: