The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo

NCT04942860 | Completed Phase 3

• 1 other identifier: WL107
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (2)

• 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

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

  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 1% methotrexate and 0.5% methotrexate gel efficacy between study participants

  12 weeks

• comparison of 1% methotrexate and 0.5% methotrexate gel efficacy between study participants

  12 weeks

• the association between disease duration and repigmentation rate in study arms

  12 weeks

Study Arms (3)

Methotrexate 1% gel

ACTIVE COMPARATOR

1% methotrexate gel applied onto a predefined limb

Drug: 1% Methotrexate gel

Methotrexate 0.5% gel

ACTIVE COMPARATOR

0.5% methotrexate gel applied onto a predefined limb

Drug: 0.5% Methotrexate gel

Vehicle gel

PLACEBO COMPARATOR

Vehicle gel applied onto a predefined limb

Drug: 1% Methotrexate gel; Drug: 0.5% Methotrexate gel

Interventions

1% Methotrexate gel DRUG

1% methotrexate gel applied onto a predefined limb

Also known as: methotrexate

Methotrexate 1% gel; Vehicle gel

0.5% Methotrexate gel DRUG

0.5% methotrexate gel applied onto a predefined limb

Also known as: methotrexate

Methotrexate 0.5% gel; Vehicle gel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

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

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: June 2, 2021
• First Posted: June 29, 2021
• Study Start: October 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: August 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)