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

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ClinicalTrials.gov Identifier: NCT03247400
Recruitment Status : Unknown
Verified April 2018 by Rafal Czajkowski, Nicolaus Copernicus University.
Recruitment status was:  Recruiting
First Posted : August 11, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rafal Czajkowski, Nicolaus Copernicus University

Tracking Information
First Submitted Date  ICMJE August 5, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date April 5, 2018
Actual Study Start Date  ICMJE December 1, 2016
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
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. [ Time Frame: 12 weeks ]
change from baseline in repigmentation on BSA and VASI scale at 12 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
  • the association between disease duration and repigmentation rate in study arms [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 weeks ]
    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 BSA scale [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
  • the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate [ Time Frame: 12 weeks ]
    the association between estimated daily ointment use (grams per square centimeter skin) and repigmentation rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
Official Title  ICMJE The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo (EVRAAS)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-segmental Vitiligo
Intervention  ICMJE
  • Drug: 1% simvastatin-acid sodium salt ointment
    1% simvastatin-acid sodium salt ointment applied onto a predefined limb
    Other Name: simvastatin
  • Drug: 1% atorvastatin calcium salt ointment
    1% atorvastatin calcium salt ointment applied onto a predefined limb
    Other Name: atorvastatin
Study Arms  ICMJE
  • Active Comparator: 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
    Intervention: Drug: 1% simvastatin-acid sodium salt ointment
  • Active Comparator: 1% atorvastatin calcium salt ointment
    1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb
    Intervention: Drug: 1% atorvastatin calcium salt ointment
  • Placebo Comparator: Vehicle ointment
    Placebo ointment applied onto limbs opposite to treated with active substances
    Interventions:
    • Drug: 1% simvastatin-acid sodium salt ointment
    • Drug: 1% atorvastatin calcium salt ointment
Publications * Niezgoda A, Winnicki A, Kosmalski T, Kowaliszyn B, Krysiński 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03247400
Other Study ID Numbers  ICMJE NCU 631
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rafal Czajkowski, Nicolaus Copernicus University
Study Sponsor  ICMJE Nicolaus Copernicus University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Nicolaus Copernicus University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP