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Completed

NCT Number: NCT03247400

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

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

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Key information

Conditions

Non-Segmental Vitiligo

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz

Bydgoszcz, Cuiavian-Pomeranian, 85094, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

1% simvastatin-acid sodium salt ointment

Drug

1% simvastatin-acid sodium salt ointment applied onto a predefined limb

Other names: simvastatin

1% atorvastatin calcium salt ointment

Drug

1% atorvastatin calcium salt ointment applied onto a predefined limb

Other names: atorvastatin

Primary outcomes

  1. evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt ointments compared to vehicle ointments after a 12-week study period.

    Time frame: 12 weeks

    change from baseline in repigmentation on BSA and VASI scale at 12 weeks

Secondary outcomes

  1. number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 12 weeks

    number of adverse events and serious adverse events associated with treatment

  2. percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in lesional skin area

    Time frame: 12 weeks

    number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in lesional skin area (in sqare centimeters)

  3. percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in BSA scale

    Time frame: 12 weeks

    number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in BSA scale

  4. percentage of patients who achieved particular response rate as follows none 0%; poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% in each arm assessed as a relative reduction in VASI scale

    Time frame: 12 weeks

    number of: poor 1-25%; moderate 26-50%; good 51-75%; excellent >75% responders in each arm assessed as a relative reduction in VASI scale

  5. comparison of simvastatin and atorvastatin efficacy between study participants

    Time frame: 12 weeks

    comparison of BSA and VASI scale change between simvastatin and atorvastatin arms

  6. the association between disease duration and repigmentation rate in study arms

    Time frame: 12 weeks

    the association between disease duration and repigmentation rate in study arms

  7. the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate

    Time frame: 12 weeks

    the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate

Sponsors and collaborators

Lead sponsor

Nicolaus Copernicus University

Other

Registry information

Official study title

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

Acronym: EVRAAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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