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

Nicolaus Copernicus University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-segmental Vitiligo

Treatments: Drug: 1% atorvastatin calcium salt ointment; Drug: 1% simvastatin-acid sodium salt ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT03247400

NCU 631

Details and patient eligibility

About

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

Full 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 single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 20 active non-segmental vitiligo patients presenting with vitiligous lesions on both upper and lower limbs. Clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

1% simvastatin-acid sodium salt ointment

Active Comparator group

Description:

1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb

Treatment:

Drug: 1% simvastatin-acid sodium salt ointment

1% atorvastatin calcium salt ointment

Active Comparator group

Description:

1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb

Treatment:

Drug: 1% atorvastatin calcium salt ointment

Vehicle ointment

Placebo Comparator group

Description:

Placebo ointment applied onto limbs opposite to treated with active substances

Treatment:

Drug: 1% simvastatin-acid sodium salt ointment

Drug: 1% atorvastatin calcium salt ointment