Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

NCT ID: NCT05315128

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-12-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-melanoma Skin Cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Double-blinded

Study Groups

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Intralesional methotrexate

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.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

A randomized comparative effectiveness clinical trial

Intramuscular methotrexate

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.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

A randomized comparative effectiveness clinical trial

Interventions

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Methotrexate

A randomized comparative effectiveness clinical trial

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Basma Magdy Elkholy, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB# 6029/-6-7-2020

Identifier Type: -

Identifier Source: org_study_id

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