Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Non-melanoma Skin Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315128
• Other study ID #: IRB# 6029/-6-7-2020
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2020
• Est. completion date: December 6, 2021

Study information

• Verified date: April 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 6, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-melanoma Skin Cancers
• Skin Neoplasms

Intervention

Drug:
• Methotrexate
A randomized comparative effectiveness clinical trial

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 1 month after the last session
Secondary	Adverse effects		Starting from the first session and up to 6-months after the last session
Secondary	Recurrence	after achieving response greater than 50% of the tumor	till the end of follow up duration (6 months)
Secondary	New NMSC lesions elsewhere		from the start of the study and till the end of follow up period (6 months)