Forehead Lines
Conditions
Keywords
Forehead Lines, OnabotulinumtoxinA, FHL Japan P3
Brief 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. 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.
Interventions
DRUGOnabotulinumtoxinA
Intramuscular Injections
DRUGPlacebo
Intramuscular Injections
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 \[SARS-CoV-2\]).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 30 | The investigator assesses FHL severity using the FWS-A scale ranging from none to severe. |
| Number of Participants with Adverse Events (AEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Achieved 'None' or 'Mild' on FWS-A According to the Participant Assessment of FHL Severity | Day 30 | The participant assesses FHL severity using the FWS-A scale ranging from none to severe. |
| 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 | Day 30 | The investigator assesses FHL severity using the FWS-A scale ranging from none to severe. |
| 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 | Day 30 | For participants rated as at least mild at baseline, the investigator assesses FHL severity using the FWS-A scale ranging from none to severe. |
| 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 | Day 30 | The investigator assesses FHL severity using the FWS-A scale ranging from none to severe. |
| Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Treatment on the Facial Line Satisfaction Questionnaire (FLSQ) | Day 60 | 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. |
| Percentage of Participants with Responder Status of 'Very Satisfied' or 'Mostly Satisfied' on Satisfaction with Natural Look on the FLSQ | Day 30 | 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. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the SKIN-Q Scale | Day 30 | The SKIN-Q Scale is a scale that measures the appearance of skin quality response option ranging from Very dissatisfied to Very satisfied. |
| Change from Baseline in the Participant's Rasch-Transformed Score of the FACE-Q Social Function Scale at the Final Visit | Day 30 | The FACE-Q Psychological Function is a scale that measures psychological function with options ranging from definitely disagree to definitely agree. |
Countries
Japan
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed