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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01452594
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female between 18 and 60 years of age
* Able to give verbal and written informed consent
* For women of childbearing potential (WOCBP) or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and for one month following the last dose of study medication). Acceptable forms of contraception are listed in the protocol.
* Must have a negative urine pregnancy test (for WOCBP)
Exclusion Criteria:
* Subjects taking any of the following systemic or topical therapies within 4 weeks of enrollment: corticosteroids, immunosuppressants, and/or any other medications that may affect the outcome of the study
* Known sensitivity to bandage or adhesive tape.
* Subjects who have active localized or systemic medical conditions that, in the opinion of the investigator, would preclude or make unsafe their participation in the study
* Subjects with any underlying concomitant diagnosis that may influence immune reactions (e.g. eczema, psoriasis, lupus)
* Subjects who are nursing mothers, pregnant, or planning to become pregnant at anytime during the course of the study or within 30 days of study completion
* Subjects who are unable to comply with study procedures, communicate effectively, cooperate with the investigator, or are unable to understand the study
* Subjects who have been treated with another investigational device or drug within 30 days of enrollment
* HIV positive as determined by self-reported history and/or a HIV POCT at screening
* History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, make the candidate ineligible for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01452594
Study Brief:
Protocol Section:
NCT01452594