TO-208 Clinical Pharmacology Study - Open-Label Study to Evaluate the Safety, Efficacy, and Plasma Concentrations of TO-208 in Patients Aged 2 Years and Older with Molluscum Contagiosum -

Torii Pharmaceutical Co.,Ltd0 个研究点目标入组 18 人开始时间: 2023年7月27日最近更新: 2025年6月9日

适应症

试验速览

暂无简介。

•Patients who have at least 21 treatable Molluscum Contagiosum lesions confirmed by the investigator before the initial study drug application at Visit 2 and whose guardian agrees that the treatable Molluscum Contagiosum lesions will be treated
•Patients who have no previous diseases considered to be medically serious by the investigator and whose concurrent diseases other than Molluscum Contagiosum are considered to be mild or less severe and controlled
•Patients who are able to refrain from using all topical products including sunscreens within 4 hours before the study drug application
•Patients who are able to refrain from bathing and swimming which may wash out the study drug until it 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 with Molluscum Contagiosum lesions in the genital region
•Patients with Molluscum Contagiosum lesions accompanied by dermatitis
•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

Plasma drug concentration

Determined by assay with a lower limit of quantitation (LLOQ) of 2.5 ng/mL

Proportion of subjects achieving complete clearance of all treatable Molluscum Contagiosum lesions(each visit after the initial study drug application)
Proportion of subjects exhibiting a 90% or greater reduction of all treatable Molluscum Contagiosum lesions(Visit 7 or the day of completion of the study)
Proportion of subjects exhibiting a 75% or greater reduction of all treatable Molluscum Contagiosum lesions(Visit 7 or the day of completion of the study)
Percent reduction of all treatable Molluscum Contagiosum lesions(Visit 7 or the day of completion of the study)
Change from baseline in the score from the Children's Dermatology Life Quality Index (CDLQI) assessment(each visit)

发起方

Torii Pharmaceutical Co.,Ltd