JRCT ID: jRCT2031220567
Registered date:12/01/2023
A phase II/III Study of M610101 in Patients with Atopic Dermatitis
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Atopic dermatitis |
Date of first enrollment | 28/01/2023 |
Target sample size | 270 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | M6101:0.75% or 1.5% BID placebo:BID |
Outcome(s)
Primary Outcome | Proportion of participants achieving IGA score of 0 or 1 with improvement from baseline at week 8 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 12age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients with atopic dermatitis over 12 years old Patients with an IGA score of 2 or 3 for atopic dermatitis |
Exclude criteria | Patients complicated with diseases considered inappropriate for participation in clinical trials such as serious cardiac / hepatic / renal / pulmonary / hematologic disease Patients with skin diseases other than atopic dermatitis that affect the evaluation of atopic dermatitis or the safety of the subject |
Related Information
Primary Sponsor | Tomoyuki Nishiura |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | - Clinical Trials Information |
Address | 93 chudoji Awatacho, Shimogyo-ku, Kyoto Kyoto Japan 600-8815 |
Telephone | +81-75-325-3279 |
ctinfo@mii.maruho.co.jp | |
Affiliation | Maruho Co.,Ltd. Kyoto R&D Center |
Scientific contact | |
Name | Nishiura Tomoyuki |
Address | 93 chudoji Awatacho, Shimogyo-ku, Kyoto Kyoto Japan 600-8815 |
Telephone | +81-75-325-3279 |
ctinfo@mii.maruho.co.jp | |
Affiliation | Maruho Co.,Ltd. Kyoto R&D Center |