Status:
COMPLETED
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
Lead Sponsor:
Nicolaus Copernicus University
Conditions:
Non-segmental Vitiligo
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.
Detailed Description
According to available data, statins act through several immunological pathways, potentially reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. A study has been designed as a...
Eligibility Criteria
Inclusion
- patients of Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz
- provision of an informed consent form prior to any study procedures
- diagnosis of non-segmental acrofacial vitiligo with upper and lower limbs involvement
- active vitiligo, defined as appearance of new areas of depigmentation or progression of existing areas of depigmentation within 3 months preceding screening
- male or non-pregnant female patients aged 18 to 80 years
- confirmed valid health insurance
- all inclusion criteria must be met
Exclusion
- pregnancy or breast-feeding
- diagnosis of segmental, mixed, unclassified or undefined vitiligo
- hypersensitivity to simvastatin or atorvastatin
- any statins use within 8 weeks preceding eligibility screening
- 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
- phototherapy due to vitiligo or any other medical conditions within the 4-week period preceding eligibility screening
- any topical or systemic additional vitiligo treatment (e.g. antioxidants, ginkgo biloba, dermo-cosmetics) within 4 weeks preceding screening
- surgical treatment of vitiligous lesions within past 4 weeks
- hypersensitivity to statins
- decompensated autoimmune or internal diseases
- alcohol or drug abuse
- skin malignancies (currently or history of skin malignancy within 5 years preceding screening)
- presence of skin characteristics that may interfere with study assessments
- patients currently participating in any other clinical study
- uncooperative patients
- none of the above can be met
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03247400
Start Date
December 1 2016
End Date
April 30 2019
Last Update
September 23 2020
Active Locations (1)
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1
Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
Bydgoszcz, Cuiavian-Pomeranian, Poland, 85094