Allergic diseases caused by Alternaria
Conditions
Interventions
TO-211, comparater (Allergen Scratch Extract "Torii" Alternaria), negative control and positive control will be administered one drop at a time to the flexor side of the forearm of the subject. These
Sponsors
Kaneko Shinya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants with either or both asthma or/and nasal allergy symptoms and have a history of treatment for allergic symptoms within the past 3 years. - Subjects who meet any of the following criteria: 1) Subjects who have Class 2 or higher Alternaria-specific IgE antibody test results within 3 years prior to the date of informed consent 2) Subjects who have not undergone an Alternaria specific IgE antibody test within 3 years prior to the date of informed consent
Exclusion criteria
Exclusion criteria: - Subjects with skin diseases, scars (including tattoos), and other treatment marks that may affect the evaluation of skin reactions on the flexor surface of the forearm on both sides - Subjects with a history of or concurrent machinery urticaria - Subjects with a history of serious drug allergy or those who have experienced systemic allergic symptoms in skin testing such as skin prick test(SPT), scratch tests, and intradermal tests in the past - Subjects who used the following medications on the day of SPT or the day before 1) B(beta) 2 agonists (but not including the use of inhalants) 2) Topical agents on the flexor surfaces of the forearms on both sides - Subjects who used the following drugs on the day of and within 7 days before SPT 1) Antihistamines (injection, oral, or topical application to the flexor surface of the forearm on both sides), including OTC drugs 2) Antipsychotics with antihistamine effects (chlorpromazine, levomepromazine, clozapine, olanzapine, etc.) 3) Adrenal corticosteroids (injection, oral or rectal) - Subjects with the use of long-term and high-dose systemic Adrenal corticosteroids (injection or oral) that may affect the immediate-type reactions in SPT - Subjects who used topical preparations containing the following ingredients at the flexor surfaces of the forearms on both sides on the day of and within 21 days before SPT 1) Adrenal corticosteroids (including OTC drugs) 2) Immunosuppressants - Subjects with asthma-like symptoms corresponding to moderate persistent or severer asthma according to Classification of asthma or childfood asthma severity on the day of and within 28 days before SPT - Patients with asthma showing a deteriorating trend of symptoms accompanied by seizure or dyspnea on the day of SPT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic concordance of the TO-211 compared with the existing extract according to the acceptance criterion-1* *Acceptance criterion-1: A wheal with a longest diameter at least 2 times larger than the negative control or larger than 5 mm at 15 minutes after pricking is considered a positive reaction. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Positive agreement between the TO-211 and comparator according to the acceptance criteria-1, 2, 3, 4, 5, and 6 - Diagnostic concordance of the TO-211 compared with the comparator according to the acceptance criteria-2, 3, 4, 5, and 6 - Negative agreement between the TO-211 and comparator according to the acceptance criteria-1, 2, 3, 4, 5, and 6 - Diagnostic concordance, positive agreement, and negative agreement of the TO-211 compared with the diagnosis based on the Alternaria-specific IgE antibody test (Class 2 or higher, or below Class 2)* according to the acceptance criteria-1, 2, 3, 4, 5, and 6 - Diagnostic concordance, positive agreement, and negative agreement of the TO-211 in subjects with concordant diagnosis between the skin test using the comparator and the Alternaria-specific IgE antibody test (Class 2 or higher, or below Class 2)* according to the acceptance criteria-1, 2, 3, 4, 5, and 6 *: Using results of Alternaria-specific IgE antibody tests conducted in this study - Comparison of the longest, shortest, and mean wheal diameters between the comparator and TO-211 - Comparison of the longest, shortest, and mean erythema diameters between the comparator and TO-211 - Diagnostic concordance, positive agreement, and negative agreement of the TO-211 according to acceptance criteria-3 and 5 as compared with acceptance criterion-1 - Diagnostic concordance, positive agreement, and negative agreement of the TO-211 according to acceptance criteria-4 and 6 as compared with acceptance criterion-2 *Acceptance criterion 1: A wheal with a longest diameter at least 2 times larger than the negative control or larger than 5 mm at 15 minutes after pricking is considered a positive reaction. 2: A wheal with a mean diameter at least 2 times larger than the negative control or larger than 5 mm at 15 minutes after pricking is considered a positive reaction. 3: A wheal with a longest diameter 3 mm or larger at 15 minutes after pricking is considered a positive reaction. 4: | — |
Contacts
Public ContactShinya Kaneko
Torii Pharmaceutical Co.,Ltd
Outcome results
None listed