TO-208 Clinical Pharmacology Study

JRCT ID: jRCT2031230204

Registered date:05/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Molluscum Contagiosum
• Date of first enrollment: 27/07/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): To determine the plasma concentrations of TO-208 at 2 hours and 24 hours after the initial application and to evaluate the efficacy and safety of dermal application of TO-208 when applied once every 21 days for up to 4 applications in Japanese pediatric Molluscum Contagiosum patients aged 2 to 15 years.

Outcome(s)

• Primary Outcome: Plasma drug concentration (determined by assay with a lower limit of quantitation [LLOQ] of 2.5 ng/mL)

Secondary Outcome

- Proportion of subjects achieving complete clearance of all treatable Molluscum Contagiosum lesions (baseline and new after Visit 2) at each visit after the initial study drug application
- Proportion of subjects exhibiting a 90% or greater reduction of all treatable Molluscum Contagiosum lesions (baseline and new after Visit 2) at 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 (baseline and new after Visit 2) at Visit 7 or the day of completion of the study
- Percent reduction of all treatable Molluscum Contagiosum lesions (baseline and new after Visit 2) at 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 at each visit

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Kaneko Shinya