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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive onabotulinumtoxinA Dose A in both Period 1 and Period 2. |
|
| Group 2 | Experimental | Participants will receive onabotulinumtoxinA Dose B in both Period 1 and Period 2. |
|
| Group 3 | Experimental | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose A in Period 2. |
|
| Group 4 | Experimental | Participants will receive placebo in Period 1 and onabotulinumtoxinA Dose B in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnabotulinumtoxinA | Drug | Intramuscular Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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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 |
|---|---|---|---|---|---|---|
| Hiroshima Station Clinic /ID# 268467 | Hiroshima | Hiroshima | 732-0053 | Japan | ||
| Kotoni Tower Skin And Cosmetic Surgery Clinic /ID# 268460 |
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 investigator assesses FHL severity using the FWS-A scale ranging from none to severe. |
| 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. | 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. | 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. | 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. | 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. | 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. | Day 30 |
| Sapporo |
| Hokkaido |
| 063-0812 |
| Japan |
| Tokai University Hospital /ID# 268496 | Isehara | Kanagawa | 259-1193 | Japan |
| Queens Square Medical Center, Dermatology and Allergology /ID# 268454 | Yokohama | Kanagawa | 220-6208 | Japan |
| Jun Clinic /ID# 268531 | Nagano | Nagano | 380-0826 | Japan |
| Touyama Plastic Surgery Clinic /ID# 268456 | Naha | Okinawa | 900-0015 | Japan |
| Yoshikawa Skin Clinic /ID# 268494 | Takatsuki | Osaka | 569-0824 | Japan |
| Tokyo Center Clinic /ID# 268477 | Chuo-ku | Tokyo | 103-0027 | Japan |
| Tokyo Asbo Clinic /ID# 268529 | Chuo-ku | Tokyo | 104-0031 | Japan |
| Ginza Skin Clinic /ID# 268532 | Chuo-ku | Tokyo | 104-0061 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 268499 | Minato-ku | Tokyo | 108-8642 | Japan |
| Forest Palace Dermatology Clinic /ID# 268599 | Nerima-ku | Tokyo | 177-0041 | Japan |
| Greenwood Skin Clinic Tachikawa /ID# 268528 | Tachikawa-shi | Tokyo | 190-0023 | Japan |
| Chiharu Dermatology Clinic Urawa /ID# 268497 | Saitama | 333-0055 | Japan |
| Akihabara Skin Clinic /ID# 268441 | Tokyo | 101-0021 | Japan |
| 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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