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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.
Details
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 150 |
| Start date | 2025-01-22 |
| Completion | 2026-04-03 |
Conditions
- Forehead Lines
Interventions
- OnabotulinumtoxinA
- Placebo
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 — 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.
Countries
Japan