Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Zagazig University60 enrolled

Overview

to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management

Intralesional methotrexate (MTX) could to be promising conservative alternative for non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced NMSC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Non-melanoma Skin Cancers

Interventions

MethotrexateDRUG

A randomized comparative effectiveness clinical trial

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Adult patients of both sexes with histologically-confirmed primary or recurrent non- metastatic NMSCs of different types (BCC,SCC, and/or KA), sites, number, sizes and duration were included in the study. Exclusion Criteria: • Hypersensitivity reactions to methotrexate, liver or kidney disease, immunosuppressive conditions, HIV, HBV, and HCV infection, hematological abnormalities and metastasis. Pregnant or lactating women, females in their child-bearing period not using or refusing contraceptive methods, and those who had any other form of NMSC management in the month preceding enrollment.

Locations (1)

Zagazig university

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

Reduction in size and number of tumors

Patients were divided into 3 groups: responders (if the tumor has regressed by \> 50%), partial responders (tumor regression \< 50%), and non- responders (no improvement at all or worsening).

Time frame: up to 1 month after the last session

Secondary Outcomes

Adverse effects

Time frame: Starting from the first session and up to 6-months after the last session

Recurrence

after achieving response greater than 50% of the tumor

Time frame: till the end of follow up duration (6 months)

New NMSC lesions elsewhere

Time frame: from the start of the study and till the end of follow up period (6 months)

Data from ClinicalTrials.gov

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