Investigation of mast cell-stimulating factors using blood from subjects with chronic spontaneous urticaria

JRCT ID: jRCT1030230097

Registered date:26/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic spontaneous urticaria
• Date of first enrollment: 20/06/2023
• Target sample size: 35
• Study type: Observational

Outcome(s)

• Primary Outcome: The amount of MRGPRX2 levels in plasma-derived extracellular vesicles

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

Patients with chronic spontaneous urticaria (CSU)
1)Patients who were diagnosed as chronic spontaneous urticaria following the criteria of the Japanese Dermatological Association Guidelines.
2)Patients who were not administered any medications other than antihistamines and adjunctive therapies as defined by the guidelines of the Japanese Dermatological Association, with symptom of urticaria at least 4 times a week for more than 4 weeks and persisting for more than 4 weeks, moderate and severe CSU patients (UAS7 >= 16, ISS7 >= 6 and HSS7 >= 6), and who had never received omalizumab.
3)Patients aged between 16 and 70 years at the time of consent,regardless of gender

Healthy control subjects
1)Subjects aged between 16 and 70 years at the time of consent,regardless of gender
2)Subjects who are not diagnosed as chronic spontaneous urticaria following the criteria of the Japanese Dermatological Association

• Exclude criteria: Patients with chronic spontaneous urticaria who were administered corticosteroids or immunosuppressive drugs within 4 weeks prior to the study

Related Information

• Primary Sponsor: Hayama Koremasa
• Secondary Sponsor: Ide Tomohiro,KYORIN Pharmaceutical Co.,Ltd.