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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT03945760
Eligibility Criteria:
Inclusion Criteria:
* Males 18-40 years of age at the time of signing the informed consent document
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
* Able to adhere to the study visit schedule and other protocol requirements
* Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities
Exclusion Criteria:
* Any known severe allergies to yeast products
* Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
* Inability to understand informed consent
* Any medical condition that the investigator feels would interfere with study
* Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
* Agree to discontinue use of prohibited medications at least 4 weeks prior to screening:
topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines
* Positive reaction to tuberculin test (PPD) or negative control
* Negative reaction to initial skin testing for Candida, Trichophyton, or Sodium Laurel Sulfate
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03945760
Study Brief:
Protocol Section:
NCT03945760