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

NCT ID: NCT06794866

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Forehead Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injections

Group 2

Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injections

Group 3

Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injections

Placebo

Intervention Type DRUG

Intramuscular Injections

Group 4

Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2.

Group Type EXPERIMENTAL

OnabotulinumtoxinA

Intervention Type DRUG

Intramuscular Injections

Placebo

Intervention Type DRUG

Intramuscular Injections

Interventions

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OnabotulinumtoxinA

Intramuscular Injections

Intervention Type DRUG

Placebo

Intramuscular Injections

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Hiroshima Station Clinic /ID# 268467

Hiroshima, Hiroshima, Japan

Site Status

Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460

Sapporo, Hokkaido, Japan

Site Status

Tokai University Hospital /ID# 268496

Isehara, Kanagawa, Japan

Site Status

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

Yokohama, Kanagawa, Japan

Site Status

Jun Clinic /ID# 268531

Nagano, Nagano, Japan

Site Status

Touyama Plastic Surgery Clinic /ID# 268456

Naha, Okinawa, Japan

Site Status

Yoshikawa Skin Clinic /ID# 268494

Takatsuki, Osaka, Japan

Site Status

Tokyo Center Clinic /ID# 268477

Chuo-ku, Tokyo, Japan

Site Status

Tokyo Asbo Clinic /ID# 268529

Chuo-ku, Tokyo, Japan

Site Status

Ginza Skin Clinic /ID# 268532

Chuo-ku, Tokyo, Japan

Site Status

Kitasato University Kitasato Institute Hospital /ID# 268499

Minato-ku, Tokyo, Japan

Site Status

Forest Palace Dermatology Clinic /ID# 268599

Nerima-ku, Tokyo, Japan

Site Status

Greenwood skin clinic Tachikawa /ID# 268528

Tachikawa-shi, Tokyo, Japan

Site Status

Chiharu Dermatology Clinic Urawa /ID# 268497

Saitama, , Japan

Site Status

Akihabara Skin Clinic /ID# 268441

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M24-697

Related Info

Other Identifiers

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M24-697

Identifier Type: -

Identifier Source: org_study_id

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