A Phase 3, Multicenter, Double-blind, Randomized, Placebo controlled, Parallel group Study to Evaluate the Efficacy and Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines in Japanese Adults (A Study to Evaluate the Efficacy and Safety of MT10109L Compared with Placebo for the Treatment of Glabellar Lines in Japanese Adults)

Medytox Inc.0 个研究点目标入组 150 人开始时间: 待定最近更新: 2025年2月18日

试验速览

阶段: 不适用
状态: 招募中
发起方: Medytox Inc.
入组人数: 150
主要终点: Proportion of participants with none/minimal or mild rating at maximum frown

暂无简介。

•Participant must be between >=18 years and <65 years of age and considered to be an adult in her/his local jurisdiction at the time of signing the informed consent.
•Japanese participant is with moderate to severe GL at maximum frown (as assessed by the investigator) using the MGLS.
•Participant is male or female.
•Contraceptive use by male or female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
•Participant is capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
•Written ICF has been obtained from the participant prior to any study-related procedures.
•Written documentation has been obtained in accordance with the relevant Japan and local privacy requirements, where applicable.
•Ability to follow study instructions and likely to complete all required visits.

•Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
•Infection or skin disorder at the injection sites.
•3 Any uncontrolled systemic disease.
•Recent history of alcohol or drug abuse based on the investigator's judgment.
•Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
•Any condition which precludes a participant's ability to comply with study requirements, including completion of the study visit or inability to read, understand.
•The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

Proportion of participants with none/minimal or mild rating at maximum frown

时间窗: Day 30

The proportion of participants who achieve a rating of none/minimal or mild at maximum frown according to investigator assessment using the MGLS

Proportion of participants who achieve a rating of none/minimal or mild at maximum frown at Day 60 after the first treatment(Day 60 after the first treatment)
Proportion of participants who achieve a rating of none/minimal or mild at maximum frown at Day 90 after the first treatment(Day 90 after the first treatment)

发起方