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中等度から重度の眉間皺を有する日本人被験者におけるAGN-151586の臨床試験

基本情報

NCT ID
NCT06151561
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
24
治験依頼者名
AbbVie

概要

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.

対象疾患

Moderate to Severe Glabellar Lines

介入

AGN-151586(DRUG)
Placebo(DRUG)

依頼者(Sponsor)

実施施設 (1)

医療法人社団知正会 東京センタークリニック

Central District, Tokyo, Japan