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

Non-segmental Vitiligo Clinical Trial

— EVRAAS  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247400
• Other study ID #: NCU 631
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2016
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2020
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-segmental Vitiligo
• Vitiligo

Intervention

Drug:
• 1% simvastatin-acid sodium salt ointment
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

Locations

Country	Name	City	State
Poland	Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz	Bydgoszcz	Cuiavian-Pomeranian

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline in repigmentation on BSA and VASI scale at 12 weeks	12 weeks
Secondary	number of participants with treatment-related adverse events as assessed by CTCAE v4.0	number of adverse events and serious adverse events associated with treatment	12 weeks
Secondary	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	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)	12 weeks
Secondary	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	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	12 weeks
Secondary	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	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	12 weeks
Secondary	comparison of simvastatin and atorvastatin efficacy between study participants	comparison of BSA and VASI scale change between simvastatin and atorvastatin arms	12 weeks
Secondary	the association between disease duration and repigmentation rate in study arms	the association between disease duration and repigmentation rate in study arms	12 weeks
Secondary	the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate	the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate	12 weeks