Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Forehead Lines
Keywords: Forehead Lines
BOTOX
Botulinum Toxin Type A
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-12-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 30
measure: Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
timeFrame: Day 30
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 180
Secondary outcomes:
measure: Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity
timeFrame: Baseline to Day 30
measure: 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
timeFrame: Day 60
measure: Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ follow up Item 4
timeFrame: Day 30
measure: Percentage of Participants who Achieved at Least a 20-Point Psychosocial Impact Improvement from Baseline on the FLSQ Impact Domain
timeFrame: Baseline to Day 30
measure: Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity
timeFrame: Baseline to Day 30
measure: Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline on FWS-A According to the Participant Assessment of FHL Severity
timeFrame: Baseline to Day 30
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital /ID# 250059
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 249912
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital /ID# 250742
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148
state: Guangdong
city: Shenzhen
country: China
facility: Peking university shenzhen hospital /ID# 249913
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 250022
state: Hubei
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 250020
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 249970
state: Jiangsu
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 249854
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 249856
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 250474
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital /ID# 250120
state: Zhejiang
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: