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The aim of this study is to evaluate the influence of two concentrations of methotrexate on vitiligous lesions in patients with non-segmental vitiligo
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate 1% gel | Active Comparator | 1% methotrexate gel applied onto a predefined limb |
|
| Methotrexate 0.5% gel | Active Comparator | 0.5% methotrexate gel applied onto a predefined limb |
|
| Vehicle gel | Placebo Comparator | Vehicle gel applied onto a predefined limb |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Methotrexate gel | Drug | 1% methotrexate gel applied onto a predefined limb |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rafał Czajkowski, Prof. | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Dermatology, Sexually Transmitted Diseases and Immunodermatology, Nicolaus Copernicus University, Faculty of Medicine in Bydgoszcz | Bydgoszcz | Cuiavian-Pomeranian | 85094 | Poland |
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| 0.5% Methotrexate gel | Drug | 0.5% methotrexate gel applied onto a predefined limb |
|
|
| 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 | 12 weeks |
| comparison of 1% methotrexate and 0.5% methotrexate gel efficacy between study participants | comparison of BSA scale change between study arms | 12 weeks |
| comparison of 1% methotrexate and 0.5% methotrexate gel efficacy between study participants | comparison of VASI scale change between study arms | 12 weeks |
| the association between disease duration and repigmentation rate in study arms | the association between disease duration and repigmentation rate in study arms | 12 weeks |
| rate of adverse events during treatment as assessed by CTCAE v4.0 | number of adverse events related to study treatment | 12 weeks |
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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