The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo (EVRAAS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: 1% simvastatin-acid sodium salt ointment (Drug)
1% atorvastatin calcium salt ointment
1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
干预措施: 1% atorvastatin calcium salt ointment (Drug)
Vehicle ointment
Placebo ointment applied onto limbs opposite to treated with active substances
干预措施: 1% simvastatin-acid sodium salt ointment (Drug)
Vehicle ointment
Placebo ointment applied onto limbs opposite to treated with active substances
干预措施: 1% atorvastatin calcium salt ointment (Drug)
结局指标
主要结局
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.
时间窗: 12 weeks
change from baseline in repigmentation on BSA and VASI scale at 12 weeks
次要结局
- number of participants with treatment-related adverse events as assessed by CTCAE v4.0(12 weeks)
- 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)
- 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)
- 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)
- comparison of simvastatin and atorvastatin efficacy between study participants(12 weeks)
- the association between disease duration and repigmentation rate in study arms(12 weeks)
- the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate(12 weeks)
研究者
Rafal Czajkowski
Clinical Professor
Nicolaus Copernicus University