Molluscum Contagiosum
Conditions
Interventions
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 f
Sponsors
Kaneko Shinya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -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 | — |
Contacts
Public ContactShinya Kaneko
Torii Pharmaceutical Co.,Ltd
Outcome results
None listed