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Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Primary Purpose

Non-melanoma Skin Cancers

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Methotrexate

About this trial

This is an interventional treatment trial for Non-melanoma Skin Cancers focused on measuring Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intralesional methotrexate

Intramuscular methotrexate

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Adverse effects

Recurrence

after achieving response greater than 50% of the tumor

New NMSC lesions elsewhere

Full Information

NCT ID

NCT05315128

First Posted

February 15, 2022

Last Updated

April 6, 2022

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT05315128

Brief Title

Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

July 6, 2020 (Actual)

Primary Completion Date

August 10, 2021 (Actual)

Study Completion Date

December 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-melanoma Skin Cancers

Keywords

Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

Double-blinded

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intralesional methotrexate

Arm Type

Active Comparator

Arm Description

Arm Title

Intramuscular methotrexate

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

A randomized comparative effectiveness clinical trial

Primary Outcome Measure Information:

Title

Reduction in size and number of tumors

Description

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).

Time Frame

up to 1 month after the last session

Secondary Outcome Measure Information:

Title

Adverse effects

Time Frame

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

Title

Recurrence

Description

after achieving response greater than 50% of the tumor

Time Frame

till the end of follow up duration (6 months)

Title

New NMSC lesions elsewhere

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Zagazig university

City

Zagazig

State/Province

Sharkia

ZIP/Postal Code

44519

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

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