Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05315128

Enrollment

Registered

2022-04-07

Start date

2020-07-06

Completion date

2021-12-06

Last updated

2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-melanoma Skin Cancers

Keywords

Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma

Brief summary

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

Detailed 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.

Interventions

DRUGMethotrexate

A randomized comparative effectiveness clinical trial

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Masking description

Double-blinded

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Reduction in size and number of tumors	up to 1 month after the last session	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).

Secondary

Measure	Time frame	Description
Adverse effects	Starting from the first session and up to 6-months after the last session	—
Recurrence	till the end of follow up duration (6 months)	after achieving response greater than 50% of the tumor
New NMSC lesions elsewhere	from the start of the study and till the end of follow up period (6 months)	—

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026