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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 : Recruiting
First Posted : August 11, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rafal Czajkowski, Nicolaus Copernicus University

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.

Condition or disease Intervention/treatment Phase
Non-segmental Vitiligo Drug: 1% simvastatin-acid sodium salt ointment Drug: 1% atorvastatin calcium salt ointment Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 30, 2019


Arm Intervention/treatment
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
Drug: 1% simvastatin-acid sodium salt ointment
1% simvastatin-acid sodium salt ointment applied onto a predefined limb
Other Name: simvastatin

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
Drug: 1% atorvastatin calcium salt ointment
1% atorvastatin calcium salt ointment applied onto a predefined limb
Other Name: atorvastatin

Placebo Comparator: Vehicle ointment
Placebo ointment applied onto limbs opposite to treated with active substances
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247400


Contacts
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Contact: Anna Niezgoda, MD +48 606889288 anna.niezg@gmail.com
Contact: Rafal Czajkowski, Prof NCU +48 52585 4568 r.czajkowski@cm.umk.pl

Locations
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Poland
Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz Recruiting
Bydgoszcz, Cuiavian-Pomeranian, Poland, 85094
Contact: Anna Niezgoda, MD    +48 606889288    anna.niezg@gmail.com   
Sponsors and Collaborators
Nicolaus Copernicus University
Investigators
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rafal Czajkowski, Clinical Professor, Nicolaus Copernicus University
ClinicalTrials.gov Identifier: NCT03247400     History of Changes
Other Study ID Numbers: NCU 631
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Vitiligo
Hypopigmentation
Calcium
Calcium, Dietary
Atorvastatin
Simvastatin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors