臨床研究等提出・公開システム

An Open Label Study Assessing the Safety and Tolerability of SB206 in Japanese subjects with Molluscum Contagiosum

An Open Label Study Assessing the Safety and Tolerability of SB206 in Japanese subjects with Molluscum Contagiosum

Yoshiyuki Kaneko

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

clinicaltrials-info@sato-seiyaku.co.jp

Clinical Trials Information Desk

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

+81-3-5412-7329

clinicaltrials-info@sato-seiyaku.co.jp

Complete

June. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Japanese patients with molluscum contagiosum aged 2 years or older and in good general health;
- Patients who are able to understand and follow study instructions or who have support from the parent or legal guardian;
- Patients who have a documented informed consent from voluntary signed by subject or a representative (parent or legal guardian) who received full explanations regarding the objectives and details of the study and the study drug."

- Patients who have molluscum contagiosum only in periocular area;
- Patients who have received any treatment for molluscum contagiosum during the 14 days prior to Baseline;
- Patients who are suspected to be immunosuppressed or have immunodeficiency disorder, or are on immunosuppressive treatment;
- Patients who have history or presence of clinically significant medical, psychiatric, or emotional condition that, in opinion of the investigator, would compromise the safety of the subject or the quality of the data."

Both

Molluscum contagiosum

SB206 is applied once daily for 12 weeks.

Safety and Tolerability

+81-42-648-5551

May. 25, 2023

+81-3-6779-8166

May. 25, 2023

No

none