A Phase III Long-Term Study of M610101 in Patients with Atopic Dermatitis

JRCT ID: jRCT2031220566

Registered date:12/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 24/01/2023
• Target sample size: 200
• Study type: Interventional
• Intervention(s): M6101:0.75% or 1.5% BID

Outcome(s)

Primary Outcome

Safety after long-term application of M610101 (up to 52 weeks)
(adverse events, laboratory tests, vital signs, ECG)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• 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