Non-melanoma Skin CancersPhase 2NCT05315128
Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers
A Phase 2 study testing Methotrexate in people with Non-melanoma Skin Cancers, run by Zagazig University at 1 site in Egypt.
Trial summary
to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Non-melanoma Skin Cancers
- What is being tested?
- Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2020to 6 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers
to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management
Read the 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.
- Conditions
- Non-melanoma Skin Cancers
- Being tested
- Methotrexate
- Keywords
- Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma
- Medical subject headings
- Keratoacanthoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
A randomized comparative effectiveness clinical trial
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 month after the last session
Secondary outcomes (3)
Adverse effects
Measured: Starting from the first session and up to 6-months after the last session
Recurrence
after achieving response greater than 50% of the tumor
Measured: till the end of follow up duration (6 months)
New NMSC lesions elsewhere
Measured: from the start of the study and till the end of follow up period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start6 Jul 2020
- Primary completion10 Aug 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancersStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basma Magdy Elkholy, MD, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315128
- Sponsor's protocol ID
- IRB# 6029/-6-7-2020
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Methotrexate Versus Intramuscular Methotrexate in the Treatment of Non-melanoma Skin Cancers
- ClinicalTrials.gov ID
- NCT05315128
- Acronym / sponsor ID
- IRB# 6029/-6-7-2020
- Conditions
- Non-melanoma Skin Cancers
- Keywords
- Non-melanoma skin cancer, Intralesional methotrexate, Systemic methotrexate, Intramuscular methotrexate, Keratoacanthoma, Basal cell carcinoma, Squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional methotrexate | Active comparator | Drug: MethotrexateGroup 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 | Drug: MethotrexateGroup 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateA randomized comparative effectiveness clinical trial | Drug | Intralesional methotrexate, Intramuscular methotrexate |
Primary outcome
Reduction in size and number of tumors
Time frame: 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).
3 secondary outcomes
Adverse effects
Time frame: Starting from the first session and up to 6-months after the last session
Recurrence
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate in people with Non-melanoma Skin Cancers, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in size and number of tumors (time frame: up to 1 month after the last session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.