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Completed

NCT Number: NCT05315128

Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

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

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Key information

Conditions

Non-melanoma Skin Cancers Carcinoma Carcinoma, Basal Cell Carcinoma, Squamous Cell Keratoacanthoma Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methotrexate

Drug

A randomized comparative effectiveness clinical trial

Primary outcomes

  1. Reduction in size and number of tumors

    Time frame: 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 outcomes

  1. Adverse effects

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

  2. Recurrence

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

    after achieving response greater than 50% of the tumor

  3. New NMSC lesions elsewhere

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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