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

NCT ID: NCT03247400

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2019-04-30

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 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.

Conditions

Non-segmental Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1% simvastatin-acid sodium salt ointment

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

Group Type: ACTIVE_COMPARATOR

1% simvastatin-acid sodium salt ointment

Intervention Type: DRUG

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

1% atorvastatin calcium salt ointment

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

Group Type: ACTIVE_COMPARATOR

1% atorvastatin calcium salt ointment

Intervention Type: DRUG

1% atorvastatin calcium salt ointment applied onto a predefined limb

Vehicle ointment

Placebo ointment applied onto limbs opposite to treated with active substances

Group Type: PLACEBO_COMPARATOR

1% simvastatin-acid sodium salt ointment

Intervention Type: DRUG

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

1% atorvastatin calcium salt ointment

Intervention Type: DRUG

1% atorvastatin calcium salt ointment applied onto a predefined limb

Interventions

1% simvastatin-acid sodium salt ointment

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

Intervention Type: DRUG

1% atorvastatin calcium salt ointment

1% atorvastatin calcium salt ointment applied onto a predefined limb

Intervention Type: DRUG

Other Intervention Names

simvastatin; atorvastatin

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicolaus Copernicus University

OTHER

Sponsor Role: lead

Responsible Party

Rafal Czajkowski

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafal Czajkowski, Prof NCU

Role: PRINCIPAL_INVESTIGATOR

Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz

Locations

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

Bydgoszcz, Cuiavian-Pomeranian, Poland

Countries

Poland

References

Niezgoda A, Winnicki A, Krysinski J, Niezgoda P, Nowowiejska L, Czajkowski R. Topical application of simvastatin acid sodium salt and atorvastatin calcium salt in vitiligo patients. Results of the randomized, double-blind EVRAAS pilot study. Sci Rep. 2024 Jun 25;14(1):14612. doi: 10.1038/s41598-024-65722-w.

Reference Type: DERIVED

PMID: 38918590 (View on PubMed)

Niezgoda A, Winnicki A, Kosmalski T, Kowaliszyn B, Krysinski J, Czajkowski R. The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial. Trials. 2019 Jan 25;20(1):78. doi: 10.1186/s13063-018-3168-4.

Reference Type: DERIVED

PMID: 30683146 (View on PubMed)

Other Identifiers

NCU 631

Identifier Type: -

Identifier Source: org_study_id