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

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Forehead Lines

Treatments: Drug: OnabotulinumtoxinA; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06794866

M24-697

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: OnabotulinumtoxinA

Group 2

Experimental group

Description:

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

Treatment:

Drug: OnabotulinumtoxinA

Group 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: OnabotulinumtoxinA

Group 4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: OnabotulinumtoxinA