Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Zagazig University

Status and phase: Completed; Phase 2

Conditions: Non-melanoma Skin Cancers

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT05315128

IRB# 6029/-6-7-2020

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intralesional methotrexate

Active Comparator group

Description:

Group A 30 patients received intralesional injection of MTX with an insulin syringe into the tumor at a dose ranging between 12.5 mg to 25 mg according to the tumor size every week until complete improvement or for a maximum of 8 sessions.

Treatment:

Drug: Methotrexate

Intramuscular methotrexate

Active Comparator group

Description:

Group B 30 patients received systemic MTX (SC, or IM) was injected at a dose of 25 mg every week until clearance or for a maximum of 8 sessions.

Treatment:

Drug: Methotrexate