Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe GL in Japanese participants.
AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan.
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks.
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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
|
| Dose 2 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
|
| Dose 3 | Experimental | Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. |
|
| Placebo | Placebo Comparator | Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151586 | Drug | Intramuscular Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a >= 2-grade improvement from baseline on the Facial Wrinkle Scale with Asian (FWS-A) Guide according to investigator assessment of Glabellar Lines (GL) severity at maximum frown, at any timepoint through Day 7 | Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity. | Baseline (Day 1) through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a >= 2-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time | Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity. | Baseline (Day 1) through End of Study (Up to Day 42) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Center Clinic /ID# 257898 | Central District | Tokyo | 103-0028 | Japan |
Not provided
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Intramuscular Injection |
|
| Percentage of participants with a >= 1-grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown over time | Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity. | Baseline (Day 1) through End of Study (Up to Day 42) |
| Percentage of participants with a None or Mild on the FWS-A according to investigator assessment of GL severity at maximum frown over time | Investigators' assessments of the severity of GL using the 4-grade FWS-A, where 0=none and 3=severe. Higher grades indicate more severity. | Baseline (Day 1) through End of Study (Up to Day 42) |