UMIN ID: UMIN000056931
Registered date:10/02/2025
Retrospective Observational Study of Atopic Dermatitis Patient Treated with Tralokinumab in Japanese Real-world Practice
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | atopic dermatitis |
| Date of first enrollment | 2025/02/01 |
| Target sample size | 125 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Distribution of IGA scores from the start of Tralokinumab administration at16 weeks |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Cases where tralokinumab was clearly used outside its approved indications. Patients with prior experience participating in clinical trials for tralokinumab. Patients who have refused to participate in this study (i.e., refused the use of their medical records). The opportunity for research subjects to refuse the use of their medical records in this study (opt-out) will be ensured. |
Related Information
| Primary Sponsor | EBC&M LLC |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | LEO Pharma K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Motohiro Honda |
| Address | Shibamatsuobiru 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo-to Japan 1050011 |
| Telephone | 0364353833 |
| crs5-info@ebc-m.com | |
| Affiliation | EBC&M LLC Clinical Division |
| scientific contact | |
| Name | Kenji Kabashima |
| Address | Fukuda Building 2F, 1-8-9 Uchikanda, Chiyoda-ku, 101-0047,Tokyo, Japan Japan |
| Telephone | 03-6435-3868 |
| info@npo-hifu.net | |
| Affiliation | Professor, Department of Dermatology, Kyoto University Nonprofit Organization Health Institute Research of Skin Department of Dermatology |