A Phase 2, Randomized, Double-Blind, does-finding, Parallel Group, Multi-Center Study to evaluate Efficacy and Safety of M118103 in Subjects with Prurigo nodularis.

JRCT ID: jRCT2031210028

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prurigo nodularis
• Date of first enrollment: 18/06/2021
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Patients apply investigatuional drug to evaluation site twice a day (in the morning and night).

Outcome(s)

• Primary Outcome: The ratio of patients whose thickness of evaluational nodule is decreased over 50 % .

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Prurigo nodularis patients.
• Exclude criteria: Patients who have skin symptoms that could effect on evaluation of effectiveness of investigational drug.

Related Information

• Primary Sponsor: Nishiura Tomoyuki