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to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | A randomized comparative effectiveness clinical trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Starting from the first session and up to 6-months after the last session | |
| Recurrence | after achieving response greater than 50% of the tumor | till the end of follow up duration (6 months) |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig university | Zagazig | Sharqia Province | 44519 | Egypt |
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| ID | Term |
|---|---|
| D007636 | Keratoacanthoma |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Double-blinded
| New NMSC lesions elsewhere | from the start of the study and till the end of follow up period (6 months) |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |