A Study to Assess the Adverse Events and Effectiveness of BOTOX Injections for the Treatment of Moderate to Severe Forehead Lines in Chinese Adult Participants

AbbVie

Status and phase: Completed; Phase 3

Conditions: Forehead Lines

Treatments: Drug: Placebo; Drug: BOTOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06174688

M22-043

Details and patient eligibility

About

Facial lines (such as glabellar lines [GL], lateral canthal lines [LCL], and forehead lines [FHL]) are perhaps the most visible signs of aging. Hyperfunctional facial lines that develop from repeated facial expression may be 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 BOTOX in Chinese adults with moderate to severe FHL.

Participants are placed in 1 of 2 groups, called treatment arms. Around 140 adult participants with moderate to severe FHL will be enrolled in the study.

Participants in the treatment group will receive intramuscular injections on Day 1 and followed for up to 180 Days.

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: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sufficient visual acuity without the use of eyeglasses (contact lens use acceptable) to accurately assess their facial wrinkles.
• Participant must have symmetrical FHL of moderate or severe rating at maximum contraction as assessed by both investigator and participant using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
• Participant must have glabellar lines (GL) severity of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.

Exclusion criteria

• Participants with history of known immunization or hypersensitivity to any botulinum toxin serotype.
• Participants with history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
• Presence of tattoos, jewelry, or clothing which obscures or interferes with the target area of interest and cannot be removed.
• Participant with history of treatments to the mid- or upper face.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

BOTOX

Experimental group

Description:

BOTOX will be injected on Day 1

Treatment:

Drug: BOTOX

Placebo

Placebo Comparator group

Description:

Placebo will be injected on Day 1

Treatment:

Drug: Placebo