[M24-697] 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

JRCT ID: jRCT2061240117

Registered date:28/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Forehead Lines
• Date of first enrollment: 28/01/2025
• Target sample size: 150
• Study type: Interventional

Intervention(s)

In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles.
Group 1: Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.
Group 2: Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.
Group 3: Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.
Group 4: Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.

Outcome(s)

Primary Outcome

1.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
[Time Frame: Day 30]
2.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.

Secondary Outcome

3.Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity [Time Frame: Day 30]
4.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 [Time Frame: Day 30]
5.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 [Time Frame: Day 30]
6.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 [Time Frame: Day 30]
7.Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ) [Time Frame: Day 60]
8.Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ [Time Frame: Day 30]
9.Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale [Time Frame: Day 30]
10.Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
[Time Frame: Day 30]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include 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]).

Exclude 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.

Related Information

• Primary Sponsor: Yajima Yoko