NCT03247400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

August 5, 2017

Last Update Submit

September 21, 2020

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (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.

    change from baseline in repigmentation on BSA and VASI scale at 12 weeks

    12 weeks

Secondary Outcomes (7)

  • number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    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

    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

    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

    12 weeks

  • comparison of simvastatin and atorvastatin efficacy between study participants

    12 weeks

  • +2 more secondary outcomes

Study Arms (3)

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

Drug: 1% simvastatin-acid sodium salt ointment

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

Drug: 1% atorvastatin calcium salt ointment

Vehicle ointment

PLACEBO COMPARATOR

Placebo ointment applied onto limbs opposite to treated with active substances

Drug: 1% simvastatin-acid sodium salt ointmentDrug: 1% atorvastatin calcium salt ointment

Interventions

1% simvastatin-acid sodium salt ointmentDRUG

1% simvastatin-acid sodium salt ointment applied onto a predefined limb

Also known as: simvastatin
1% simvastatin-acid sodium salt ointmentVehicle ointment
1% atorvastatin calcium salt ointmentDRUG

1% atorvastatin calcium salt ointment applied onto a predefined limb

Also known as: atorvastatin
1% atorvastatin calcium salt ointmentVehicle ointment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz

Bydgoszcz, Cuiavian-Pomeranian, 85094, Poland

Location

Related Publications (2)

  • 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.

    PMID: 38918590DERIVED

  • 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.

    PMID: 30683146DERIVED

MeSH Terms

Interventions

SimvastatinAtorvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 5, 2017

First Posted

August 11, 2017

Study Start

December 1, 2016

Primary Completion

December 31, 2018

Study Completion

April 30, 2019

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)