[M24-008] A Phase 3, Multicenter, Randomized, Placebo-Controlled Study of AGN-151586 for the Treatment of Moderate to Severe Glabellar Lines

JRCT ID: jRCT2031240348

Registered date:20/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Glabellar Lines
• Date of first enrollment: 30/10/2024
• Target sample size: 16
• Countries of recruitment: Taiwan,Japan,China,Japan
• Study type: Interventional
• Intervention(s): Based upon randomization on Baseline Day 1, subjects will receive either AGN-151586 750 U or placebo administered as 5 intramuscular injections in the glabellar complex.

Outcome(s)

Primary Outcome

2 grade improvement from baseline on the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) according to investigator assessment of GL severity at maximum frown at Day 7
2 grade improvement from baseline on the FWS-A according to subject assessment of GL severity at maximum frown at Day 7

Secondary Outcome

2 grade improvement from baseline on the FWS-A according to subject assessment of GL severity at maximum frown at Hour 24
2 grade improvement from baseline on the FWS-A according to investigator assessment of GL severity at maximum frown at Hour 24
Mostly satisfied or Very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 (overall satisfaction) for GL at Hour 24

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Adult, over 18 years of age, having moderate or severe GL at maximum frown (as assessed by the evaluating investigator and subject using the FWS-A at Screening and Baseline Day 1). The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.
• Exclude criteria: Adult, over 18 years of age, having moderate or severe GL at maximum frown (as assessed by the evaluating investigator and subject using the FWS-A at Screening and Baseline Day 1). The investigator and subject ratings must match within a visit but do not have to match between Screening and Baseline Day 1.

Related Information

• Primary Sponsor: Yajima Yoko
• Secondary ID(s): NCT06308198