Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Phase 2

Completed

• Conditions: Non-melanoma Skin Cancers
• Interventions: Drug: Methotrexate

• Registration Number: NCT05315128
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2020-07-06
• Primary Completion: 2021-08-10
• Study Completion: 2021-12-06
• Study First Submitted: 2022-02-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intralesional methotrexate	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.
Intramuscular methotrexate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
New NMSC lesions elsewhere	from the start of the study and till the end of follow up period (6 months)
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

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt