Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05315128

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-melanoma Skin Cancers	Drug: Methotrexate	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Double-blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2020

Actual Primary Completion Date :

Aug 10, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Methotrexate A randomized comparative effectiveness clinical trial
Active Comparator: 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.	Drug: Methotrexate A randomized comparative effectiveness clinical trial

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Methotrexate

A randomized comparative effectiveness clinical trial

Active Comparator: 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.

Drug: Methotrexate

A randomized comparative effectiveness clinical trial

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.