Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005389-32 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the biological activity of Juniperus oxycedrus and Cupressus arizonica. allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
The trial will consist of a single visit, in which the following procedures will be carried out:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extract J. oxycedrus + extract C. arizonica + positive control + negative control | Experimental | There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10 mg/mL) and the negative control, with prick test. Juniperus oxycedrus: 300, 60 and 12 µg/mL Cupressus arizonica: 100, 20 and 4 µg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergenic extract | Other | In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the induced papule on the skin | Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test. | 15 minutes |
| Adverse reactions | Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.). | 30 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Javier Subiza, DM | Clinica Subiza, centro de asma y alergia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Subiza, centro de asma y alergia | Madrid | Madrid | Spain |
Not provided
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C451253 | grass pollen extract, alum-adsorbed |
Not provided
Not provided
Not provided
Phase II, open-label, non-randomized trial, with no control group of subjects.
Not provided
Not provided
Not provided
Not provided
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |