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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 -

TO-208 Clinical Pharmacology Study

17

In the pharmacokinetic analysis set and full analysis set (FAS), subjects' sex was 25.0% (4/16 subjects) for males, and mean age at the time of obtaining informed consent was 5.0 years old (range: 2-8 years old). By age category, 56.3% (9/16 subjects) were aged 2 to 5 years and 43.8% (7/16 subjects) were aged 6 to 11 years, and no subjects aged 12 years and older were enrolled. Mean molluscum contagiosum lesions count (standard deviation) was 56.4 (25.4).

After informed consent was obtained from 17 subjects, 1 subject judged by the investigator to be inappropriate for participation in the study was excluded due to meeting the exclusion criteria. Sixteen subjects who met the inclusion criteria and did not meet the exclusion criteria were enrolled and started study treatment. No subjects were withdrawn, and all subjects completed the study.

No death was reported, and no serious TEAEs, TEAEs leading to drug withdrawn, or adverse drug reactions leading to drug interrupted were observed. The incidence of adverse drug reactions to TO-208 was 100%, and most of them were local skin reactions.

The cantharidin (unchanged drug) in plasma was detected in 2 of 16 subjects (at 2 hours after the initial study drug application in both subjects) . The unchanged plasma drug concentrations were near lower limit of quantitation (LLOQ, 2.5 ng/mL), but were below the LLOQ at 24 hours after the initial study drug application. The remaining 14 subjects had unchanged plasma drug concentrations that were below the LLOQ in all plasma samples. Proportion of subjects achieved complete clearance of all treatable molluscum contagiosum lesions was 0.0% (0/16 subjects) at Day 22, 18.8% (3/16 subjects) at Day 43, 61.5% (8/13 subjects) at Day 64, and 20.0% (1/5 subjects) at Day 85 in the FAS analysis. Four of 16 subjects did not achieve complete clearance of molluscum contagiosum lesions at Day 85 after up to 4 applications of TO-208.

These results indicated that systemic exposure to TO-208 was rarely observed.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031230204

Kaneko Shinya

Torii Pharmaceutical Co.,Ltd

4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo 103-8439, Japan

shinya.kaneko@torii.co.jp

Kaneko Shinya

Torii Pharmaceutical Co.,Ltd

4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo 103-8439, Japan

+81-80-1383-7582

shinya.kaneko@torii.co.jp

Complete

July. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

Both

Molluscum Contagiosum

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.

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 (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

+81-42-648-5551

June. 22, 2023

+81-3-3881-6116

June. 22, 2023

+81-48-852-1111

June. 22, 2023

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