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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX | Experimental | BOTOX will be injected on Day 1 |
|
| Placebo | Placebo Comparator | Placebo will be injected on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOTOX | Drug | Intramuscular Injections |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity | The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital /ID# 250059 | Beijing | Beijing Municipality | 100730 | China | ||
| Peking University First Hospital /ID# 249912 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo | Drug | Intramuscular Injections |
|
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. |
| 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 | 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. | Day 30 |
| Percentage of Participants who Achieved at Least a 20-Point Psychosocial Impact Improvement from Baseline on the FLSQ Impact Domain | 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. | 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 | The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe. | Baseline to Day 30 |
| Percentage of Participants who Achieved at least 2-Grade Improvement from Baseline 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. | Baseline to Day 30 |
| Xicheng District |
| Beijing Municipality |
| 100034 |
| China |
| Guangdong Second Provincial General Hospital /ID# 250742 | Guangzhou | Guangdong | 510310 | China |
| The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148 | Guangzhou | Guangdong | 510630 | China |
| Peking university shenzhen hospital /ID# 249913 | Shenzhen | Guangdong | 518036 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 250022 | Wuhan | Hubei | 430022 | China |
| Nanjing Drum Tower Hospital /ID# 250020 | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University /ID# 249970 | Nanjing | Jiangsu | 210009 | China |
| Huashan Hospital, Fudan University /ID# 249854 | Shanghai | Shanghai Municipality | 200040 | China |
| Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 249856 | Xi’an | Shanxi | 710038 | China |
| West China Hospital, Sichuan University /ID# 250474 | Chengdu | Sichuan | 610041 | China |
| Zhejiang Provincial People's Hospital /ID# 250120 | Hangzhou | Zhejiang | 310014 | China |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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