A Phase 2 interventional study of Methotrexate in Non-melanoma Skin Cancers, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Zagazig University · Phase 2, Interventional, and Treatment
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 60 is above the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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).
Time frame: up to 1 month after the last session
Adverse effects
Time frame: Starting from the first session and up to 6-months after the last session
Recurrence
after achieving response greater than 50% of the tumor
Time frame: till the end of follow up duration (6 months)
New NMSC lesions elsewhere
Time frame: from the start of the study and till the end of follow up period (6 months)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Zagazig University