Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01494194
Eligibility Criteria:
Inclusion Criteria:
* Males and females aged 18-60 years.
* Mould sensitised subjects diagnosed according to the EAACI/Ga2len guidelines.
* Written informed consent from the subject.
* Normally active and otherwise judged to be in good health on the basis of medical history and screening assessment.
* No allergic symptoms on the day of investigation.
Exclusion Criteria:
* Pregnancy or lactation.
* Failure to comply with the protocol.
* Medication that may interfere with wheal formation in the skin or response to DBPCFC
* Participation in another clinical study involving a SPT within 30 days prior to Visit 1 or DBPCFC within 30 days prior to DBPCFC.
* Current skin disease of any type (eczema, acne, dermatitis, etc.) on the test site(s).
* Subjects with a condition the Investigator believes would interfere with the evaluation of the subject, including proceeding to DBPCFC, or may put the subject at undue risk, e.g., a history of anaphylactic reactions and history of reactions to any component of the DBPCFC matrix other than ASP.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01494194
Study Brief:
Protocol Section:
NCT01494194