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

Phase 1

Completed

• Conditions: Non-segmental Vitiligo
• Interventions: Drug: 1% atorvastatin calcium salt ointment; Drug: 1% simvastatin-acid sodium salt ointment

• Registration Number: NCT03247400
• Lead Sponsor: Nicolaus Copernicus University

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-08-05
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% atorvastatin calcium salt ointment	1% atorvastatin calcium salt ointment	1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
1% simvastatin-acid sodium salt ointment	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
Vehicle ointment	1% simvastatin-acid sodium salt ointment	Placebo ointment applied onto limbs opposite to treated with active substances
Vehicle ointment	1% atorvastatin calcium salt ointment	Placebo ointment applied onto limbs opposite to treated with active substances

Primary Outcome Measures

Name	Time	Method
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.	12 weeks	change from baseline in repigmentation on BSA and VASI scale at 12 weeks

Secondary Outcome Measures

Name	Time	Method
number of participants with treatment-related adverse events as assessed by CTCAE v4.0	12 weeks	number of adverse events and serious adverse events associated with treatment
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	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)
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	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
comparison of simvastatin and atorvastatin efficacy between study participants	12 weeks	comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
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	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
the association between disease duration and repigmentation rate in study arms	12 weeks	the association between disease duration and repigmentation rate in study arms
the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate	12 weeks	the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate

Trial Locations

Locations (1)

Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz; 🇵🇱 Bydgoszcz, Cuiavian-Pomeranian, Poland