Non-segmental VitiligoPhase 1/2EVRAASNCT03247400
The Evaluation of Vitiligous Lesions Repigmentation After the Administration of Atorvastatin Calcium Salt and Simvastatin-acid Sodium Salt in Patients With Active Vitiligo
A Phase 1/2 study testing 1% simvastatin-acid sodium salt ointment and 1% atorvastatin calcium salt ointment in people with Non-segmental Vitiligo, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- 1% simvastatin-acid sodium salt ointment and 1% atorvastatin calcium salt ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2016to 30 Apr 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz
Bydgoszcz, Cuiavian-Pomeranian, 85094
About this study
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)
The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with non-segmental vitiligo.
Read the 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.
- Conditions
- Non-segmental Vitiligo
- Being tested
- 1% simvastatin-acid sodium salt ointment, 1% atorvastatin calcium salt ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% simvastatin-acid sodium salt ointmentDrug
Also called simvastatin
1% simvastatin-acid sodium salt ointment applied onto a predefined limb
1% atorvastatin calcium salt ointmentDrug
Also called atorvastatin
1% atorvastatin calcium salt ointment applied onto a predefined limb
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 1% atorvastatin calcium salt ointment |
| Vehicle ointment | Placebo comparator | Placebo ointment applied onto limbs opposite to treated with active substances Receives: Drug: 1% simvastatin-acid sodium salt ointment; Drug: 1% atorvastatin calcium salt ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (7)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 12 weeks
comparison of simvastatin and atorvastatin efficacy between study participants
comparison of BSA and VASI scale change between simvastatin and atorvastatin arms
Measured: 12 weeks
the association between disease duration and repigmentation rate in study arms
the association between disease duration and repigmentation rate in study arms
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start1 Dec 2016
- Primary completion31 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-segmental VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafal Czajkowski, Nicolaus Copernicus University
- Investigators
- Rafal Czajkowski, Prof NCU, Principal investigator, Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247400
- Sponsor's protocol ID
- NCU 631
- Acronym
- EVRAAS
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38918590Niezgoda 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.
PubMed 30683146
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03247400
- Acronym / sponsor ID
- EVRAAS / NCU 631
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1% simvastatin-acid sodium salt ointment | Active comparator | Drug: 1% simvastatin-acid sodium salt ointment1% simvastatin-acid sodium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb |
| 1% atorvastatin calcium salt ointment | Active comparator | Drug: 1% atorvastatin calcium salt ointment1% atorvastatin calcium salt ointment applied onto a predefined limb compared with placebo ointment applied onto an opposite limb |
| Vehicle ointment | Placebo comparator | Drug: 1% simvastatin-acid sodium salt ointment, Drug: 1% atorvastatin calcium salt ointmentPlacebo ointment applied onto limbs opposite to treated with active substances |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% simvastatin-acid sodium salt ointmentAlso: simvastatin1% simvastatin-acid sodium salt ointment applied onto a predefined limb | Drug | 1% simvastatin-acid sodium salt ointment, Vehicle ointment |
| 1% atorvastatin calcium salt ointmentAlso: atorvastatin1% atorvastatin calcium salt ointment applied onto a predefined limb | Drug | 1% atorvastatin calcium salt ointment, Vehicle ointment |
Primary outcome
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
7 secondary outcomes
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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
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
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
Time frame: 12 weeks
comparison of simvastatin and atorvastatin efficacy between study participants
Time frame: 12 weeks
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
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 38918590Niezgoda 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.
- Derived from this study: PubMed 30683146Niezgoda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafal Czajkowski, Prof NCU principal investigator
Head of Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University in Torun, Ludwik Rydygier Medical College in Bydgoszcz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 1% simvastatin-acid sodium salt ointment and 1% atorvastatin calcium salt ointment in people with Non-segmental Vitiligo, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.