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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
1% simvastatin-acid sodium salt ointment applied onto a predefined limb
1% atorvastatin calcium salt ointment applied onto a predefined limb
Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
Bydgoszcz, Cuiavian-Pomeranian, Poland
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
Time frame: 12 weeks
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
Time frame: 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
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)
Time frame: 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
Time frame: 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
Time frame: 12 weeks
comparison of simvastatin and atorvastatin efficacy between study participants
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comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
Time frame: 12 weeks
the association between disease duration and repigmentation rate in study arms
the association between disease duration and repigmentation rate in study arms
Time frame: 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
Time frame: 12 weeks