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

N

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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