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TO-208 Phase III Clinical Study
- Placebo-Controlled, Randomized, Double-Blind Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of TO-208 In Subjects Aged 2 Years and Older with Molluscum Contagiosum -

TO-208 Phase III Clinical Study

305

There were no apparent differences between the treatment groups (TO-208 group, placebo group) in demographics and baseline characteristics (age, sex, molluscum contagiosum lesion count, etc.)

A total of 303 subjects were randomized to ether the TO-208 group (148 subjects) or the placebo group (155 subjects) and administered the study drug. Of these, 137 subjects in the TO-208 group and 150 subjects in the placebo group completed the part 1 of the study. In the part 2, a total of 168 subjects (60 subjects in the TO-208 start group, 108 subjects in placebo start group) were administered the TO-208.

In the part 1, 148/148 subjects (100.0%) in the TO-208 group and 139/155 subjects (89.7%) in the placebo group experienced treatment emergent adverse events (TEAEs). Local skin reactions (LSRs) such as application site vesicles, application site scab, application site erythema, application site pain, application site pruritus were frequently reported in both the TO-208 and the placebo groups. The incidence of most of the LSRs in the TO-208 group was higher than that in the placebo group. In the part 2, 148/148 subjects (100.0%) in the TO-208 start group and 108/108 subjects (100 .0%) in the placebo start group experienced TEAEs.

The primary endpoint of "the proportion of subjects exhibiting complete clearance of all treatable molluscum contagiosum lesions" at Visit 7 was significantly higher in the TO-208 group than in the placebo group (p<0.001), demonstrating the superiority of TO-208 over placebo. In addition, the secondary endpoint of "the percent reduction of molluscum contagiosum lesion count from baseline" at Visit 7 was significantly greater in the TO-208 group than in the placebo group (p<0.001).

When TO-208 was administered to patients with molluscum contagiosum once every 21 days for up to 4 times , improvements were noted in the "the proportion of subjects exhibiting complete clearance of molluscum contagiosum lesions" and "the percent reduction of molluscum contagiosum lesion count from baseline" compared to the placebo. Regarding safety, there were no events requiring special attention other than LSRs, and it was confirmed that the TO-208 was well tolerated up to 8 applications.

Feb. 03, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2041220039

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. 11, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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

-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

Both

Molluscum Contagiosum

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.

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.

-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

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