NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Positive control of Skin Prick Test for allergy diagnosis
Date of first enrollment	09/10/2013
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : JTE-350 INN of investigational material : Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : Drop on skin control material(s) Generic name etc : Allergen Scratch Extract Contrast "Torii" INN of investigational material : Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines) Dosage and Administration for Investigational material : Drop on skin

Outcome(s)

Primary Outcome	Positive rate of JTE-350 After 15 minutes, the wheal diameter is 3mm or longer
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 65age old
Gender	Both
Include criteria	1) Healthy Volunteers 20 to 65 years of age on the day of informed consent 2) Subjects signed written informed consent
Exclude criteria	1) Subjects with a history of serious drug allergy or subjects who have ever experienced systemic allergy due to skin prick test. 2) Subjects with treatmets to affect skin prick test result, for example anti-histamine drug