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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT05235334
Eligibility Criteria:
Inclusion Criteria:
* Men and women, age 18 years or older with Fitzpatrick skin types 1,2,3,4,5 and 6.
* The patient can understand the information provided to them and who have given written informed consent to the study.
* The patient can understand and complete self-administered questionnaires.
* The patient is able and willing to follow study procedures.
* Women of child-bearing potential must confirm use of an effective contraceptive for 30 days prior to enrolling and continued use throughout the study or have a negative pregnancy test.
Exclusion Criteria:
* History of underlying photosensitivity.
* Subjects who are pregnant
* Patients that have granulomatous disorders (such as sarcoidosis).
* Use of medications that cause a photosensitivity reaction.
* History of skin cancer in the last 5 years.
* Patients with history of hypocalcemia (calcium \<8.6mg%), hypercalcemia(calcium \>10.6mg%).
* Taking drugs known to influence vitamin D metabolism, such as glucocorticoids,antiseizure medications, or HIV/AIDS medications.
* Patients with a history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease within 3 months.
* Intentional artificial UV exposure (e.g. tanning bed, UVB phototherapy use) in the last 60 days or planned use while participating in the study.
* Participation in an investigational drug study within 30 days of the screening.
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05235334
Study Brief:
Protocol Section:
NCT05235334