Forehead LinesPhase 3NCT06174688
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
A Phase 3 study testing BOTOX in people with Forehead Lines, run by AbbVie at 12 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forehead Lines
- What is being tested?
- BOTOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 12 sitesChina
- Study dates
- 12 Dec 2023to 13 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Hospital /ID# 250059
Beijing, Beijing Municipality, 100730
West China Hospital, Sichuan University /ID# 250474
Chengdu, Sichuan, 610041
Guangdong Second Provincial General Hospital /ID# 250742
Guangzhou, Guangdong, 510310
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 250148
Guangzhou, Guangdong, 510630
Zhejiang Provincial People's Hospital /ID# 250120
Hangzhou, Zhejiang, 310014
Nanjing Drum Tower Hospital /ID# 250020
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 249970
Nanjing, Jiangsu, 210009
Huashan Hospital, Fudan University /ID# 249854
Shanghai, Shanghai Municipality, 200040
Peking university shenzhen hospital /ID# 249913
Shenzhen, Guangdong, 518036
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 250022
Wuhan, Hubei, 430022
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 249856
Xi’an, Shanxi, 710038
Peking University First Hospital /ID# 249912
Xicheng District, Beijing Municipality, 100034
About this study
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
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.
Read more
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
- Being tested
- BOTOX, Placebo
- Keywords
- Forehead Lines, BOTOX, Botulinum Toxin Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOXDrug
Also called Botulinum Toxin Type A
Intramuscular Injections
PlaceboDrug
Intramuscular Injections
| Study group | Role | What they receive |
|---|---|---|
| BOTOX | Experimental | BOTOX will be injected on Day 1 Receives: Drug: BOTOX |
| Placebo | Placebo comparator | Placebo will be injected on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
The investigator assesses FHL severity using the FWS-A 4-point scale ranging from 0=None to 3=Severe.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start12 Dec 2023
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forehead LinesStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174688
- Sponsor's protocol ID
- M22-043
- Status last verified
- Aug 2025
- First submitted
- 8 Dec 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06174688
- Acronym / sponsor ID
- M22-043
- Conditions
- Forehead Lines
- Keywords
- Forehead Lines, BOTOX, Botulinum Toxin Type A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOTOX | Experimental | Drug: BOTOXBOTOX will be injected on Day 1 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOTOXAlso: Botulinum Toxin Type AIntramuscular Injections | Drug | BOTOX |
| PlaceboIntramuscular Injections | Drug | Placebo |
Primary outcome
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.
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.
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Forehead Lines
Active, not recruitingPhase 2
A Study to Assess the Safety and Efficacy of AGN-151586 Injections for the Treatment of Moderate to Severe Forehead Lines (FHL) in Adult Participants
Forehead Lines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BOTOX in people with Forehead Lines, run by AbbVie at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.