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

JRCT ID: jRCT2031230123

Registered date:08/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Molluscum contagiosum
• Date of first enrollment: 07/06/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): SB206 is applied once daily for 12 weeks.

Outcome(s)

• Primary Outcome: Safety and Tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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."

Exclude criteria

- 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."

Related Information

• Primary Sponsor: Yoshiyuki Kaneko