Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers

NCT05315128 | Completed Phase 2

• 1 other identifier: IRB# 6029/-6-7-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-melanoma Skin Cancers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• New NMSC lesions elsewhere

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

Study Arms (2)

Intralesional methotrexate

ACTIVE COMPARATOR

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

Intramuscular methotrexate

ACTIVE COMPARATOR

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

Interventions

Methotrexate DRUG

A randomized comparative effectiveness clinical trial

Intralesional methotrexate; Intramuscular methotrexate

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Keratoacanthoma; Carcinoma, Basal Cell; Carcinoma, Squamous Cell

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: April 7, 2022
• Study Start: July 6, 2020
• Primary Completion: August 10, 2021
• Study Completion: December 6, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

EG (1)