The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicolaus Copernicus University
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium; Calcium, Dietary; Simvastatin

Criteria

Inclusion Criteria:

1. patients of Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz

2. provision of an informed consent form prior to any study procedures

3. diagnosis of non-segmental 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 non-pregnant female patients aged 18 to 80 years

6. confirmed valid health insurance

all inclusion criteria must be met

Exclusion Criteria:

1. pregnancy or breast-feeding

2. diagnosis of segmental, mixed, unclassified or undefined vitiligo

3. hypersensitivity to simvastatin or atorvastatin

4. any statins use within 8 weeks preceding eligibility screening

5. systemic immunosuppressive/immunomodulating i.e. cyclosporine A, corticosteroids within 4 weeks preceding eligibility screening or azathioprine, methotrexate, mycophenolate mofetil, Janus kinase - JAK 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, dermo-cosmetics) within 4 weeks preceding screening

8. surgical treatment of vitiligous lesions within past 4 weeks

9. hypersensitivity to statins

10. decompensated autoimmune or internal diseases

11. alcohol or drug abuse

12. skin malignancies (currently or history of skin malignancy within 5 years preceding screening)

13. presence of skin characteristics that may interfere with study assessments

14. patients currently participating in any other clinical study

15. uncooperative patients

none of the above can be met