Standardization of Japanese cypress pollen antigen

JRCT ID: jRCTs031220136

Registered date:15/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Japanese cypress pollinosis
• Date of first enrollment: 15/06/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Determining threshold of skin test to Japanese cypress pollen extract in subjects having class 2 or more serum IgE specific for Japanese cypress pollen

Outcome(s)

• Primary Outcome: Positive reaction to skin tests
• Secondary Outcome: Correlation with serum IgE titer, adverse reactions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1. Japanese adults having serum IgE specific for Japanese cypress pollen equal or above class 2
2. Aged equal or more than 20 years old and less than 60 years old
3. Regardless of gender
4. Acquisition of written informed consent for participation on this clinical trial
5. Possible to visit hospital/clinic and follow

Exclude criteria

1. Subjects using drugs such as antihistamine which may affect results of skin test at examination day
2. Subjects having disease on application site of skin test
3. Subjects having experience of Japanese cedar-specific allergen immunotherapy
4. Subjects having severe asthma
5. Subjects having uncontrolled allergic diseases
6. Subjects having experience of anaphylaxis
7. Subjects having experience of hypersensitivity to adrenalin
8. Subjects having heart, liver, kidney or blood diseases or infection which may affect the outcome of examination
9. Subjects with pregnancy or breastfeeding
10. Subjects who are judged inappropriate to participate in the trial by investigator

Related Information

• Primary Sponsor: Okano Mitsuhiro
• Source(s) of Monetary Support: Japan agency for medical research and development