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 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT04872257
Eligibility Criteria:
Inclusion Criteria:
* Males or females, ≥ 18 years of age at the time of signing the informed consent document.
* ≥5% of affected skin area
* Inactive, generalized vitiligo (inactive for a minimum of 6 months). \[Inactive: No new spontaneous lesions or a rapid progression of these.\]
* Subjects who have not been treated with phototherapy previously.
* Subject who have not been treated with topical corticosteroids for at least 8 weeks or immunomodulators for at least 12 weeks.
Exclusion Criteria:
* Subjects with \<5% of affected skin area
* Subjects who use multivitamins, diuretics, lipase-inhibitors (orlistat)
* Subjects with calcium disorders (for example: primary hyperparathyroidism) or patients with hepatic/kidney failure.
* Subjects with malabsorption gastrointestinal disorders
* Pregnant women or in lactation
* Subjects with cancer
* Subjects with previous history of skin cancer (melanoma/non-melanoma)
* Photo-sensible diseases (actinic dermatitis, porphyria, xeroderma pigmentosa) or drugs
* Subjects using immunomodulator o immunosuppressor treatments
* Subjects who practice activities that require prolonged sun exposure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04872257
Study Brief:
Protocol Section:
NCT04872257