Background
Methods
Design
Objectives
Participants
Inclusion criteriaa | Exclusion criteriab |
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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 |
Intervention
Randomization and blinding
Primary outcome
Secondary outcomes
Primary outcome | Secondary outcomes |
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1. Evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt ointments compared with vehicle ointment after a 12-week study period (change from baseline in repigmentation on BSA and VASI scale). | 1. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0 2. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in lesional skin area as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 3. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in BSA scale as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 4. Percentage of patients who achieved particular response rate in each arm assessed as a relative reduction in VASI scale as follows: none, 0%; poor, 1–25%; moderate, 26–50%; good, 51–75%; excellent, > 75% 5. Comparison of simvastatin and atorvastatin efficacy between study participants 6. The association between disease duration and repigmentation rate in study arms 7. The association between estimated daily ointment use (grams per square centimeter of skin) and repigmentation rate in study arms |