A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants With Forehead Lines

NCT05152576 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: M21-606
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 8

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. OnabotulinumtoxinA X is being investigated as another form of treatment to treat FHL by inhibiting the release of the neurotransmitter that causes the overactivity of the muscles responsible for the severity of these facial lines. The purpose of this study is to evaluate the safety and change in condition of 3 doses of OnabotulinumtoxinA X for the treatment of moderate to severe forehead lines. Study doctors will determine if a subject is eligible for the study. If so, the subject will be randomized into 1 of the 4 groups, called treatment arms. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 120 adult participants with FHL will be enrolled in the study in approximately 10 sites in the United States. Participants will receive either intramuscular injections of onabotulinumtoxinA X or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at the study site.

Conditions

Forehead Lines

Keywords

Forehead Lines; OnabotulinumtoxinA X

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  Day 1 to Day 180

• Percentage of Participants With Potentially Clinically Significant Vital Sign Parameters

  Percentage of participants with potentially clinically significant vital sign measurements like systolic and diastolic blood pressure will be assessed.

  Day 1 to Day 180

• Percentage of Participants With Achievement of ≥ 1-grade Improvement From Baseline on the Investigator-rated Clinician Forehead Lines Scale at Maximum Contraction.

  Facial Wrinkle Scale - Forehead Lines (FWS-FHL) at maximum contraction (also known as eyebrow elevation) The Clinician Forehead Lines Scale is a four point scale used to assess the severity of forehead lines at maximum contraction ranging from 0 - None to 3 - Severe.

  Day 1 to Day 30

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo will be injected into the forehead on Day 1.

Drug: Placebo

OnabotulinumtoxinA X Dose A

EXPERIMENTAL

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose B

EXPERIMENTAL

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Drug: OnabotulinumtoxinA X

OnabotulinumtoxinA X Dose C

EXPERIMENTAL

OnabotulinumtoxinA X will be injected into the forehead on Day 1.

Drug: OnabotulinumtoxinA X

Interventions

OnabotulinumtoxinA X DRUG

Intramuscular Injection

Also known as: OnabotA X

OnabotulinumtoxinA X Dose A; OnabotulinumtoxinA X Dose B; OnabotulinumtoxinA X Dose C

Placebo DRUG

Intramuscular Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has sufficient visual acuity without the use of eyeglasses (contact lens use is acceptable) to accurately assess their facial lines
• Participant has moderate or severe Forehead Lines (FHL) at maximum eyebrow elevation

You may not qualify if:

• History of known immunization to any botulinum toxin serotype.
• History of known hypersensitivity to any botulinum toxin serotype, or any other constituents of the study drug or its excipients, and/or other products in the same class.
• Presence or history of any medical condition that may place the participant at increased risk following exposure to OnabotulinumtoxinA X or interfere with the study evaluation, including:
• Diagnosed myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.
• History of Facial nerve palsy.
• Infection or dermatological condition at the site of study drug injection.

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

The Eye Research Foundation /ID# 241512

Newport Beach, California, 92663-3637, United States

Location

Steve Yoelin MD Medical Associate Inc /ID# 239771

Newport Beach, California, 92663, United States

Location

The Center for Dermatology Cosmetics & Laser Surgery /ID# 239776

Mount Kisco, New York, 10549-3028, United States

Location

Skin Search of Rochester Inc. /ID# 239773

Rochester, New York, 14623, United States

Location

Dermatology Consulting Service /ID# 239779

High Point, North Carolina, 27262, United States

Location

Wilmington Dermatology Center /ID# 239778

Wilmington, North Carolina, 28403, United States

Location

Dallas Plastic Surgery Institute /ID# 239777

Dallas, Texas, 75231, United States

Location

Duplicate_Austin Institute for Clinical Research /ID# 239783

Pflugerville, Texas, 78660, United States

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Results Point of Contact

• Title: ABBVIE CALL CENTER
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

844-663-3742

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: November 29, 2021
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (8)