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The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% simvastatin-acid sodium salt ointment | Active Comparator | 1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb |
|
| 1% atorvastatin calcium salt ointment | Active Comparator | 1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb |
|
| Vehicle ointment | Placebo Comparator | Placebo ointment applied onto limbs opposite to treated with active substances |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% simvastatin-acid sodium salt ointment | Drug | 1% simvastatin-acid sodium salt ointment applied onto a predefined limb |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
all inclusion criteria must be met
Exclusion Criteria:
none of the above can be met
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| Name | Affiliation | Role |
|---|---|---|
| Rafal Czajkowski, Prof NCU | Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz | Bydgoszcz | Cuiavian-Pomeranian | 85094 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38918590 | Derived | 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. | |
| 30683146 | Derived |
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|
| 1% atorvastatin calcium salt ointment | Drug | 1% atorvastatin calcium salt ointment applied onto a predefined limb |
|
|
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 |
| 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 |
| 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 |
| comparison of simvastatin and atorvastatin efficacy between study participants | comparison of BSA and VASI scale change between simvastatin and atorvastatin arms | 12 weeks |
| the association between disease duration and repigmentation rate in study arms | 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 | the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate | 12 weeks |
| 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. |
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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