Back to resultsThe Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo (EVRAAS)
Primary Purpose
Non-segmental Vitiligo
Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
1% simvastatin-acid sodium salt ointment
1% atorvastatin calcium salt ointment
Sponsored by
About this trial
This is an interventional treatment trial for Non-segmental Vitiligo
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1% simvastatin-acid sodium salt ointment
1% atorvastatin calcium salt ointment
Vehicle ointment
Arm Description
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 applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
Placebo ointment applied onto limbs opposite to treated with active substances
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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
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
comparison of simvastatin and atorvastatin efficacy between study participants
comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
the association between disease duration and repigmentation rate in study arms
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
the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
Full Information
NCT ID
NCT03247400
First Posted
August 5, 2017
Last Updated
September 21, 2020
Sponsor
Nicolaus Copernicus University
1. Study Identification
Unique Protocol Identification Number
NCT03247400
Brief Title
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nicolaus Copernicus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-segmental Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1% simvastatin-acid sodium salt ointment
Arm Type
Active Comparator
Arm Description
1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
Arm Title
1% atorvastatin calcium salt ointment
Arm Type
Active Comparator
Arm Description
1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
Arm Title
Vehicle ointment
Arm Type
Placebo Comparator
Arm Description
Placebo ointment applied onto limbs opposite to treated with active substances
Intervention Type
Drug
Intervention Name(s)
1% simvastatin-acid sodium salt ointment
Other Intervention Name(s)
simvastatin
Intervention Description
1% simvastatin-acid sodium salt ointment applied onto a predefined limb
Intervention Type
Drug
Intervention Name(s)
1% atorvastatin calcium salt ointment
Other Intervention Name(s)
atorvastatin
Intervention Description
1% atorvastatin calcium salt ointment applied onto a predefined limb
Primary Outcome Measure Information:
Title
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.
Description
change from baseline in repigmentation on BSA and VASI scale at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
number of adverse events and serious adverse events associated with treatment
Time Frame
12 weeks
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
comparison of simvastatin and atorvastatin efficacy between study participants
Description
comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
Time Frame
12 weeks
Title
the association between disease duration and repigmentation rate in study arms
Description
the association between disease duration and repigmentation rate in study arms
Time Frame
12 weeks
Title
the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
Description
the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal Czajkowski, Prof NCU
Organizational Affiliation
Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
City
Bydgoszcz
State/Province
Cuiavian-Pomeranian
ZIP/Postal Code
85094
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30683146
Citation
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.
Results Reference
derived
Learn more about this trial
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
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