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

NCT06174688 | Completed Phase 3

• 1 other identifier: M22-043
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Forehead Lines

Keywords

Forehead Lines; BOTOX; Botulinum Toxin Type A

Outcome Measures

Primary Outcomes (3)

• 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

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

  Day 30

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

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

  Day 30

• Number of Participants with Adverse Events (AEs)

  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.

  Day 180

Secondary Outcomes (6)

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

  Baseline to Day 30

• 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

  Day 60

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

  Day 30

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

  Baseline to Day 30

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

  Baseline to Day 30

Study Arms (2)

BOTOX

EXPERIMENTAL

BOTOX will be injected on Day 1

Drug: BOTOX

Placebo

PLACEBO COMPARATOR

Placebo will be injected on Day 1

Drug: Placebo

Interventions

BOTOX DRUG

Intramuscular Injections

Also known as: Botulinum Toxin Type A

BOTOX

Placebo DRUG

Intramuscular Injections

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (12)

Beijing Hospital /ID# 250059

Beijing, Beijing Municipality, 100730, China

Location

Peking University First Hospital /ID# 249912

Xicheng District, Beijing Municipality, 100034, China

Location

Guangdong Second Provincial General Hospital /ID# 250742

Guangzhou, Guangdong, 510310, China

Location

The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148

Guangzhou, Guangdong, 510630, China

Location

Peking university shenzhen hospital /ID# 249913

Shenzhen, Guangdong, 518036, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 250022

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 250020

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 249970

Nanjing, Jiangsu, 210009, China

Location

Huashan Hospital, Fudan University /ID# 249854

Shanghai, Shanghai Municipality, 200040, China

Location

Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 249856

Xi’an, Shanxi, 710038, China

Location

West China Hospital, Sichuan University /ID# 250474

Chengdu, Sichuan, 610041, China

Location

Zhejiang Provincial People's Hospital /ID# 250120

Hangzhou, Zhejiang, 310014, China

Location

Related Links

• clinical study report synopsis

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 12, 2023
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

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: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (12)