Non-segmental VitiligoPhase 3EVRAMNCT04942860
The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo
A Phase 3 study testing 1% Methotrexate gel and 0.5% Methotrexate gel 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 two concentrations of methotrexate 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% Methotrexate gel and 0.5% Methotrexate gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2019to 31 Aug 2023
- Phase
- Phase 3
- 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 and non-breastfeeding female patients aged 18 to 80 years
- Women must use effective contraception one month preceding treatment, during treatment and 6 months after completing treatment.
- Confirmed valid health insurance
Who cannot join
- Diagnosis of segmental, mixed, unclassified or undefined vitiligo
- Pregnancy and breastfeeding
- Hypersensitivity to methotrexate or any of the excipients
- 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
Show all 19Show fewer
- Surgical treatment of vitiligous lesions within past 4 weeks
- Severe liver dysfunction [bilirubin> 5 mg / dL (85.5 μmol / L)], including cirrhosis and hepatitis
- Severe renal impairment (eGFR <20 ml / min),
- Disorders of the hematopoietic system, bone marrow disorders (leukopenia, thrombocytopenia, anemia),
- Immunodeficiencies, including HIV infection
- Severe acute or chronic infections such as tuberculosis
- Alcohol abuse
- Mouth ulcers and known active gastric or duodenal ulcer disease
- Recent surgical wounds.
- 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
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
The aim of this study is to evaluate the influence of two concentrations of methotrexate on vitiligous lesions in patients with non-segmental vitiligo
Read the detailed description
Methotrexate, synthesized in the 1950s as an anticancer drug with an antiproliferative effect, is currently one of the most commonly used immunosuppressive agents in dermatology. The use of small, non-oncological doses has revealed its anti-inflammatory properties, including the impact on a number of cytokines involved in the pathogenesis of autoimmune diseases. It has been shown that treatment with methotrexate reduces the levels of TNF-alpha-producing T cells, while the number of IL-10 producing T cells increases. Methotrexate also inhibits the synthesis of interferon-γ. The above considerations justify the use of topical methotrexate in patients with vitiligo in order to obtain repigmentation.
A study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of up to 100 active non-segmental vitiligo patients presenting with vitiligous lesions on both upper and lower limbs. Clinical effects of gel containing 1% methotrexate or 0.5% methotrexate 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% Methotrexate gel, 0.5% Methotrexate gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Methotrexate gelDrug
Also called methotrexate
1% methotrexate gel applied onto a predefined limb
0.5% Methotrexate gelDrug
Also called methotrexate
0.5% methotrexate gel applied onto a predefined limb
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate 1% gel | Active comparator | 1% methotrexate gel applied onto a predefined limb Receives: Drug: 1% Methotrexate gel |
| Methotrexate 0.5% gel | Active comparator | 0.5% methotrexate gel applied onto a predefined limb Receives: Drug: 0.5% Methotrexate gel |
| Vehicle gel | Placebo comparator | Vehicle gel applied onto a predefined limb Receives: Drug: 1% Methotrexate gel; Drug: 0.5% Methotrexate gel |
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% methotrexate or 0.5% methotrexate gels compared to vehicle gel after a 12-week study period
change from baseline in repigmentation on BSA scale at 12 weeks
Measured: 12 weeks
evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% methotrexate or 0.5% methotrexate gels compared to vehicle gel after a 12-week study period
change from baseline in repigmentation on VASI scale at 12 weeks
Measured: 12 weeks
Secondary outcomes (6)
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 1% methotrexate and 0.5% methotrexate gel efficacy between study participants
comparison of BSA scale change between study arms
Measured: 12 weeks
comparison of 1% methotrexate and 0.5% methotrexate gel efficacy between study participants
comparison of VASI scale change between study 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
rate of adverse events during treatment as assessed by CTCAE v4.0
number of adverse events related to study treatment
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 posted29 Jun 2021
- Study start1 Oct 2019
- Primary completion1 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 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
- Rafał Czajkowski, Prof., 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
- NCT04942860
- Sponsor's protocol ID
- WL107
- Acronym
- EVRAM
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo
- ClinicalTrials.gov ID
- NCT04942860
- Acronym / sponsor ID
- EVRAM / WL107
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 29 Jun 2021 (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 two concentrations of methotrexate on vitiligous lesions in patients with non-segmental vitiligo
Detailed description
Methotrexate, synthesized in the 1950s as an anticancer drug with an antiproliferative effect, is currently one of the most commonly used immunosuppressive agents in dermatology. The use of small, non-oncological doses has revealed its anti-inflammatory properties, including the impact on a number of cytokines involved in the pathogenesis of autoimmune diseases. It has been shown that treatment with methotrexate reduces the levels of TNF-alpha-producing T cells, while the number of IL-10 producing T cells increases. Methotrexate also inhibits the synthesis of interferon-γ. The above considerations justify the use of topical methotrexate in patients with vitiligo in order to obtain repigmentation.
A study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of up to 100 active non-segmental vitiligo patients presenting with vitiligous lesions on both upper and lower limbs. Clinical effects of gel containing 1% methotrexate or 0.5% methotrexate 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 |
|---|---|---|
| Methotrexate 1% gel | Active comparator | Drug: 1% Methotrexate gel1% methotrexate gel applied onto a predefined limb |
| Methotrexate 0.5% gel | Active comparator | Drug: 0.5% Methotrexate gel0.5% methotrexate gel applied onto a predefined limb |
| Vehicle gel | Placebo comparator | Drug: 1% Methotrexate gel, Drug: 0.5% Methotrexate gelVehicle gel applied onto a predefined limb |
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 and non-breastfeeding female patients aged 18 to 80 years
Key exclusion criteria (19 listed)
- Diagnosis of segmental, mixed, unclassified or undefined vitiligo
- Pregnancy and breastfeeding
- Hypersensitivity to methotrexate or any of the excipients
- 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
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% Methotrexate gelAlso: methotrexate1% methotrexate gel applied onto a predefined limb | Drug | Methotrexate 1% gel, Vehicle gel |
| 0.5% Methotrexate gelAlso: methotrexate0.5% methotrexate gel applied onto a predefined limb | Drug | Methotrexate 0.5% gel, Vehicle gel |
Primary outcome
evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% methotrexate or 0.5% methotrexate gels compared to vehicle gel after a 12-week study period
Time frame: 12 weeks
change from baseline in repigmentation on BSA scale at 12 weeks
evaluation of repigmentation of vitiligous lesions achieved after the administration of 1% methotrexate or 0.5% methotrexate gels compared to vehicle gel after a 12-week study period
Time frame: 12 weeks
change from baseline in repigmentation on VASI scale at 12 weeks
6 secondary outcomes
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 1% methotrexate and 0.5% methotrexate gel efficacy between study participants
Time frame: 12 weeks
comparison of 1% methotrexate and 0.5% methotrexate gel efficacy between study participants
Time frame: 12 weeks
the association between disease duration and repigmentation rate in study arms
Time frame: 12 weeks
rate of adverse events during treatment as assessed by CTCAE v4.0
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 11 Sep 2023.
- 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.
Rafał Czajkowski, Prof. 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 3 study testing 1% Methotrexate gel and 0.5% Methotrexate gel 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 19 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 11 Sep 2023. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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% methotrexate or 0.5% methotrexate gels compared to vehicle gel after a 12-week study period (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2023.