TO-208 Phase III Clinical Study

JRCT ID: jRCT2041220039

Registered date:24/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Molluscum Contagiosum
• Date of first enrollment: 20/07/2022
• Target sample size: 300
• Study type: Interventional
• Intervention(s): The objective of the study is to evaluate the efficacy and safety of dermal application of TO-208 or placebo, when applied once every 21 Days for up to 4 applications. The confirmatory study will be further extended to investigate the safety and efficacy of continued application, up to 4 applications, of TO-208 in an open-label extension study.

Outcome(s)

• Primary Outcome: Proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new after Visit 2) at Visit 7 or the time of discontinuation of the confirmatory study.

Secondary Outcome

-Proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new after Visit 2) at Visit 6
-Proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new after Visit 2) at Visit 5
-Proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new after Visit 2) at Visit 4
-Proportion of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions at 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 at 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 at Visit 7 or the time of discontinuation of the confirmatory study

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-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

Exclude criteria

-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

Related Information

• Primary Sponsor: Kaneko Shinya