Clinical trial
The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo
Name
WL107
Description
The aim of this study is to evaluate the influence of two concentrations of methotrexate on vitiligous lesions in patients with non-segmental vitiligo
Trial arms
Trial start
2019-10-01
Estimated PCD
2023-06-01
Trial end
2023-08-31
Status
Completed
Phase
Early phase I
Treatment
1% Methotrexate gel
1% methotrexate gel applied onto a predefined limb
Arms:
Methotrexate 1% gel, Vehicle gel
Other names:
methotrexate
0.5% Methotrexate gel
0.5% methotrexate gel applied onto a predefined limb
Arms:
Methotrexate 0.5% gel, Vehicle gel
Other names:
methotrexate
Size
25
Primary endpoint
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
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
12 weeks
Eligibility 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 and non-breastfeeding female patients aged 18 to 80 years
6. Women must use effective contraception one month preceding treatment, during treatment and 6 months after completing treatment.
7. Confirmed valid health insurance
Exclusion Criteria:
1. Diagnosis of segmental, mixed, unclassified or undefined vitiligo
2. Pregnancy and breastfeeding
3. Hypersensitivity to methotrexate or any of the excipients
4. 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
5. Phototherapy due to vitiligo or any other medical conditions within the 4-week period preceding eligibility screening
6. Any topical or systemic additional vitiligo treatment (e.g. antioxidants, ginkgo biloba, dermo-cosmetics) within 4 weeks preceding screening
7. Surgical treatment of vitiligous lesions within past 4 weeks
8. Severe liver dysfunction \[bilirubin\> 5 mg / dL (85.5 μmol / L)\], including cirrhosis and hepatitis
9. Severe renal impairment (eGFR \<20 ml / min),
10. Disorders of the hematopoietic system, bone marrow disorders (leukopenia, thrombocytopenia, anemia),
11. Immunodeficiencies, including HIV infection
12. Severe acute or chronic infections such as tuberculosis
13. Alcohol abuse
14. Mouth ulcers and known active gastric or duodenal ulcer disease
15. Recent surgical wounds.
16. Skin malignancies (currently or history of skin malignancy within 5 years preceding screening)
17. Presence of skin characteristics that may interfere with study assessments
18. Patients currently participating in any other clinical study
19. Uncooperative patients
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2023-09-11
1 organization
2 products
1 indication
Organization
Nicolaus Copernicus UniversityProduct
1% MethotrexateIndication
Non-segmental VitiligoProduct
0.5% Methotrexate