Forehead LinesPhase 3NCT06794866
A Study to Assess Adverse Events and Effectiveness of OnabotulinumtoxinA Intramuscular Injections for the Change of Moderate to Severe Forehead Lines in Adult Participants
A Phase 3 study testing OnabotulinumtoxinA in people with Forehead Lines, run by AbbVie at 15 sites in Japan.
Trial summary
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Forehead Lines
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 15 sitesJapan
- Study dates
- 22 Jan 2025to 3 Apr 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
- Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]).
Who cannot join
- FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- History of known immunization or hypersensitivity to any botulinum neurotoxin serotype.
- History of treatments to the mid or upper face.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Tokyo Center Clinic /ID# 268477
Chuo-ku, Tokyo, 103-0027
Tokyo Asbo Clinic /ID# 268529
Chuo-ku, Tokyo, 104-0031
Ginza Skin Clinic /ID# 268532
Chuo-ku, Tokyo, 104-0061
Hiroshima Station Clinic /ID# 268467
Hiroshima, Hiroshima, 732-0053
Tokai University Hospital /ID# 268496
Isehara, Kanagawa, 259-1193
Kitasato University Kitasato Institute Hospital /ID# 268499
Minato-ku, Tokyo, 108-8642
Jun Clinic /ID# 268531
Nagano, Nagano, 380-0826
Touyama Plastic Surgery Clinic /ID# 268456
Naha, Okinawa, 900-0015
Forest Palace Dermatology Clinic /ID# 268599
Nerima-ku, Tokyo, 177-0041
Chiharu Dermatology Clinic Urawa /ID# 268497
Saitama, 333-0055
Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460
Sapporo, Hokkaido, 063-0812
Greenwood Skin Clinic Tachikawa /ID# 268528
Tachikawa-shi, Tokyo, 190-0023
Yoshikawa Skin Clinic /ID# 268494
Takatsuki, Osaka, 569-0824
Akihabara Skin Clinic /ID# 268441
Tokyo, 101-0021
Queens Square Medical Center, Dermatology and Allergology /ID# 268454
Yokohama, Kanagawa, 220-6208
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in Japan
Facial lines that develop from repeated facial expression, such as forehead lines (FHL), are typically 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 onabotulinumtoxinA in Japanese adults with moderate to severe FHL.
Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan.
Read more
In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months.
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
- OnabotulinumtoxinA, Placebo
- Keywords
- Forehead Lines, OnabotulinumtoxinA, FHL Japan P3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Intramuscular Injections
PlaceboDrug
Intramuscular Injections
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2. Receives: Drug: OnabotulinumtoxinA |
| Group 2 | Experimental | Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2. Receives: Drug: OnabotulinumtoxinA |
| Group 3 | Experimental | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2. Receives: Drug: OnabotulinumtoxinA; Drug: Placebo |
| Group 4 | Experimental | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2. Receives: Drug: OnabotulinumtoxinA; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Measured: Day 30
Number of Participants with Adverse Events (AEs)
Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 12 months
Secondary outcomes (8)
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 scale ranging from none to severe.
Measured: Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Measured: Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest
For participants rated as at least mild at baseline, the investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Measured: Day 30
Time to Return to at least 'Moderate' for the Participants who Achieve Investigator FWS-A ratings of 'None' or 'Mild' on FHL Severity at Maximum Contraction
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Measured: 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)
The FLSQ assesses treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ scale ranging from Very dissatisfied to 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
The FLSQ assesses treatment satisfaction and psychosocial impact. Participants assessed their satisfaction with FHL using the FLSQ scale ranging from Very dissatisfied to Very satisfied.
Measured: Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale
The SKIN-Q Scale is a scale that measures the appearance of skin quality response option ranging from Very dissatisfied to Very satisfied.
Measured: Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
The FACE-Q Psychological Function is a scale that measures psychological function with options ranging from definitely disagree to definitely agree.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start22 Jan 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 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
- NCT06794866
- Sponsor's protocol ID
- M24-697
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA Purified Neurotoxin Complex for the Treatment of Moderate to Severe Forehead Lines in Japan
- ClinicalTrials.gov ID
- NCT06794866
- Acronym / sponsor ID
- M24-697
- Conditions
- Forehead Lines
- Keywords
- Forehead Lines, OnabotulinumtoxinA, FHL Japan P3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 27 Jan 2025 (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 that develop from repeated facial expression, such as forehead lines (FHL), are typically 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 onabotulinumtoxinA in Japanese adults with moderate to severe FHL.
Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Participants are randomly assigned to receive onabotulinumtoxinA or placebo. There is a 1 in 5 chance that a participant will receive placebo. Around 150 adult participants with moderate to severe FHL will be enrolled in the study in approximately 15 sites in Japan.
In Period 1, participants will receive intramuscular injections on Day 1. In Period 2, participants will receive up to 3 additional treatment cycles. Participants will be followed for up to 12 months.
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
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: OnabotulinumtoxinAParticipants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2. |
| Group 2 | Experimental | Drug: OnabotulinumtoxinAParticipants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2. |
| Group 3 | Experimental | Drug: OnabotulinumtoxinA, Drug: PlaceboParticipants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2. |
| Group 4 | Experimental | Drug: OnabotulinumtoxinA, Drug: PlaceboParticipants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Forehead lines (FHL) of moderate or severe rating at maximum contraction as assessed by investigator using the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) at Day 1 prior to study treatment.
- Glabellar lines (GL) of moderate or severe rating at maximum contraction as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- Good health as per the investigator's judgment based on medical history, abbreviated physical examination and vital sign measurements, including no known active pandemic infection (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]).
Key exclusion criteria (3 listed)
- FHL of severe rating at rest as assessed by investigator using the FWS-A at Day 1 prior to study treatment.
- History of known immunization or hypersensitivity to any botulinum neurotoxin serotype.
- 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 |
|---|---|---|
| OnabotulinumtoxinAIntramuscular Injections | Drug | Group 1, Group 2, Group 3, Group 4 |
| PlaceboIntramuscular Injections | Drug | Group 3, Group 4 |
Primary outcome
Percentage of Participants who Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction
Time frame: Day 30
The investigator assesses FHL severity using the FWS-A scale ranging from none to severe.
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 12 months
Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
8 secondary outcomes
Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity
Time frame: Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Maximum Contraction
Time frame: Day 30
Percentage of Participants who Achieved at least 1-Grade Improvement from Baseline on FWS-A According to the Investigator Assessment of FHL Severity at Rest
Time frame: Day 30
Time to Return to at least 'Moderate' for the Participants who Achieve Investigator FWS-A ratings of 'None' or 'Mild' on FHL Severity at Maximum Contraction
Time frame: 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)
Time frame: Day 60
Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ
Time frame: Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale
Time frame: Day 30
Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit
Time frame: 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 5 May 2026.
- 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
15 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 OnabotulinumtoxinA in people with Forehead Lines, run by AbbVie at 15 sites in Japan.
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 3 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Japan. 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. 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 Achieve 'None' or 'Mild' on Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) According to the Investigator Assessment of Forehead Lines (FHL) Severity at Maximum Contraction (time frame: Day 30). The study lists 2 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 5 May 2026.