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NCT Number: NCT06174688

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

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.

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Key information

Conditions

Forehead Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital /ID# 250059, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botox

Drug

Intramuscular Injections

Other names: Botulinum Toxin Type A

Placebo

Drug

Intramuscular Injections

Primary outcomes

  1. Percentage of Participants who Achieved 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity

    Time frame: Day 30

    The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.

  2. Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity

    Time frame: Day 30

    The participant assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.

  3. Number of Participants with Adverse Events (AEs)

    Time frame: Day 180

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

Secondary outcomes

  1. Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity

    Time frame: Baseline to Day 30

    The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.

  2. Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ) follow up Item 5

    Time frame: Day 60

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ 5-point scale ranging from -2=Very dissatisfied to 2=Very satisfied.

  3. Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ follow up Item 4

    Time frame: Day 30

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ 5-point scale ranging from -2=Very dissatisfied to 2=Very satisfied.

  4. Percentage of Participants who Achieved at Least a 20-Point Psychosocial Impact Improvement from Baseline on the FLSQ Impact Domain

    Time frame: Baseline to Day 30

    The FLSQ consists of 13 questions that assess treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ 5-point scale ranging from -2=Very dissatisfied to 2=Very satisfied.

  5. Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity

    Time frame: Baseline to Day 30

    The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.

  6. Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Participant Assessment of FHL Severity

    Time frame: Baseline to Day 30

    The participant assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3, Multi-center, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in China

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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