TO-208 Phase III Clinical Study - Placebo-Controlled, Randomized, Double-Blind Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of TO-208 In Subjects Aged 2 Years and Older with Molluscum Contagiosum -

Torii Pharmaceutical Co.,Ltd0 个研究点目标入组 300 人开始时间: 2022年7月20日最近更新: 2025年1月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 300
主要终点: Proportion of subjects achieving complete clearance of all treatable molluscum lesions

暂无简介。

•Patients who are medically healthy with no clinically significant medical history as determined by the study investigator and with mild or less severe complications other than molluscum contagiosum and controlled symptoms
•Patients who are able to refrain from using all topical products including sunscreen in 4 hours prior to the application of study drug
•Patients who are able to refrain from bathing, showering, and swimming that wash out the study drug until the study drug is removed
•Patients who are able to understand and follow the rules of the clinical study or who have support from the parent/guardian

•Patients who are determined to be unable to cooperate with the requirements or visits/telephone communication of the study
•Patients who are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents within 28 days prior to the day of informed consent
•Patients who have received any treatments for molluscum contagiosum within 14 days prior to the day of informed consent
•Patients who have a history of illness or any dermatologic disorders, which, in the opinion of the study investigator, is likely to rapidly increase the number of lesions of molluscum contagiosum or cause AEs in association with study participation
•Patients who have a history or presence of a medically significant physical, psychological, or emotional abnormality which, in the opinion of the study investigator, would compromise the safety of the patient or the quality of the data

Proportion of subjects achieving complete clearance of all treatable molluscum lesions

时间窗: Visit 7 or the time of discontinuation of the confirmatory study

Complete clearance of all treatable molluscum lesions (baseline and new after Visit 2)

Proportion of subjects achieving complete clearance of all treatable molluscum lesions at Visit 6(Visit 6)
Proportion of subjects achieving complete clearance of all treatable molluscum lesions at Visit 5(Visit 5)
Proportion of subjects achieving complete clearance of all treatable molluscum lesions at Visit 4(Visit 4)
Proportion of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions(Visit 7 or the time of discontinuation of the confirmatory study)
Proportion of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions(Visit 7 or the time of discontinuation of the confirmatory study)
Change from baseline of the total score from the Children's Dermatology Life Quality Index (CDLQI) assessment(Visit 7 or the time of discontinuation of the confirmatory study)

发起方

Torii Pharmaceutical Co.,Ltd