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:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04088357
Eligibility Criteria:
Inclusion Criteria:
* Healthy Males and Females \> 18 years of age
* Health history review
* Physical exam
* Blood and urine clinical chemistries
* Negative pregnancy test
Exclusion Criteria:
* Acute or chronic skin disorders (e.g. psoriasis);
* Acne or dermatitis at the test site;
* Prone to keloids or hypertrophic scarring;
* Topical or systemic antibiotics within 4 weeks of study enrollment;
* Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures;
* Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition;
* Morbidly obese with a Body Mass Index (BMI) ≥ 40;
* Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
* History of severe vitamin or mineral deficiency;
* History of drug or alcohol abuse (as defined by the Investigator);
* Smoking/Vaping;
* HIV/AIDS;
* Consistently taking steroids and/or non-steroidal anti-inflammatory drugs. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use;
* Cancer diagnosis in the last 5 years;
* Currently receiving chemotherapy or radiation;
* Women who are pregnant, nursing, or planning a pregnancy;
* Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields;
* Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study;
* Treatment with any investigational agent within one month before treatment application for this trial;
* Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
* Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04088357
Study Brief:
Protocol Section:
NCT04088357