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Table 1 A complete list of inclusion and exclusion criteria for the EVRAAS study

From: The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial

Inclusion criteriaa Exclusion criteriab
1. Patients of the Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
2. Provision of an informed consent form prior to any study procedures
3. Diagnosis of NSV acrofacial vitiligo with upper and lower limbs involvement
4. Active vitiligo, defined as appearance of new areas of depigmentation or progression of existing areas of depigmentation within 3 months preceding screening
5. Male or nonpregnant female patients aged 18 to 80 years
6. Confirmed valid health insurance
1. Pregnancy or breastfeeding
2. Diagnosis of segmental, mixed, unclassified, or undefined vitiligo
3. Hypersensitivity to simvastatin or atorvastatin
4. Any statin use within 8 weeks preceding eligibility screening
5. Systemic immunosuppressive/immunomodulating treatment (i.e., cyclosporine A, corticosteroids) within 4 weeks preceding eligibility screening or azathioprine, methotrexate, mycophenolate mofetil, or Janus kinase (JAK) inhibitors within 8 weeks preceding eligibility screening
6. Phototherapy due to vitiligo or any other medical conditions within the 4-week period preceding eligibility screening
7. Any topical or systemic additional vitiligo treatment (e.g., antioxidants, Ginkgo biloba, dermocosmetics) within 4 weeks preceding screening
8. Surgical treatment of vitiligous lesions within the past 4 weeks
9. Decompensated autoimmune or internal diseases
10. Alcohol or drug abuse
11. Skin malignancies (current or a history of skin malignancy within 5 years preceding screening)
12. Presence of skin characteristics that may interfere with study assessments
13. Patients currently participating in any other clinical study
14. Uncooperative patients
  1. NSV nonsegmental vitiligo
  2. aAll inclusion criteria must be met
  3. bNo exclusion criteria can be met