Localized PsoriasisNCT05408208
Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
A study testing Intralesional Injection of Methotrexate and Triamcinolone Acetonid in people with Localized Psoriasis, run by Sohag University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with Intralesional Injection of Triamcinolone Acetonid in localized psoriasis (body surface area < 10%) . Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized Psoriasis
- What is being tested?
- Intralesional Injection of Methotrexate and Triamcinolone Acetonid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 May 2022to 21 May 2023
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with localized Psoriasis (body surface area<10%)
Who cannot join
- Patient refusal. Generalized psoriasis. Pregnancy. Lactation. Immunocompromised patients . Patients with history of hypersensitivity to methotrexate. Patients with other inflammatory skin disorders. Patients with chronic hepatic, renal , pulmonary ,or haematological disorders. patients on treatment for psoriasis .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Gehad Hamdy, 01104269431, gehad011074@med.sohag.edu.eg
About this study
Official title: Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
The aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with Intralesional Injection of Triamcinolone Acetonid in localized psoriasis (body surface area < 10%) .
Read the detailed description
study enrolling 30 patients of localized psoriasis. 15 patients received intralesional methotrexate :
- Taking aseptic condition ,One psoriatic plaque will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2.
- Another plaque will treated with intralesional ingection of distilled water as controlled plaque.
- patient will receive oral folic acid 5mg tablet every day except the day of injection.
Other 15 patients received intralesional trimethinolone acetonide:
- Taking aseptic condition , One plaque will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 .
- another plaque will treated with Intralesional injection of distilled water as controed plaque.
- Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .
- Conditions
- Localized Psoriasis
- Being tested
- Intralesional Injection of Methotrexate, Triamcinolone Acetonid
- Keywords
- Intralesional Injection ,Methotrexate, localized Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional Injection of MethotrexateDrug
One psoriatic lesion will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm Another plaque will treated with intralesional ingection of distilled water as controlled plaque.
Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .
Triamcinolone AcetonidDrug
One lesion will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 . another plaque will treated with Intralesional injection of distilled water as controed plaque Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Active comparator | Intralesional injection of methotrexate Receives: Drug: Intralesional Injection of Methotrexate; Drug: Triamcinolone Acetonid |
| Triamcinolone Acetonid | Active comparator | Intralesional injection of trimethinolone acetonide Receives: Drug: Intralesional Injection of Methotrexate; Drug: Triamcinolone Acetonid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
clinical and dermoscopic changes according to psoriasis area severity index
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start21 May 2022
- Primary completion21 Nov 2022 (estimated)
- Study completion21 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized PsoriasisStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Hamdy Abdelgaber, Sohag University
- Investigators
- Gehad Hamdy, Principal investigator, Gehad Hamdy Abd El-Gaber
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408208
- Sponsor's protocol ID
- soh-med-22-05-04
- Status last verified
- Jun 2022
- First submitted
- 22 May 2022
- Last updated
- 7 Jun 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
- ClinicalTrials.gov ID
- NCT05408208
- Acronym / sponsor ID
- soh-med-22-05-04
- Conditions
- Localized Psoriasis
- Keywords
- Intralesional Injection ,Methotrexate, localized Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 21 May 2022 (actual)
- Primary completion
- 21 Nov 2022 (estimated)
- Study completion
- 21 May 2023 (estimated)
- First posted
- 7 Jun 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.
The aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with Intralesional Injection of Triamcinolone Acetonid in localized psoriasis (body surface area < 10%) .
Detailed description
study enrolling 30 patients of localized psoriasis. 15 patients received intralesional methotrexate :
- Taking aseptic condition ,One psoriatic plaque will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2.
- Another plaque will treated with intralesional ingection of distilled water as controlled plaque.
- patient will receive oral folic acid 5mg tablet every day except the day of injection.
Other 15 patients received intralesional trimethinolone acetonide:
- Taking aseptic condition , One plaque will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 .
- another plaque will treated with Intralesional injection of distilled water as controed plaque.
- Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Active comparator | Drug: Intralesional Injection of Methotrexate, Drug: Triamcinolone AcetonidIntralesional injection of methotrexate |
| Triamcinolone Acetonid | Active comparator | Drug: Intralesional Injection of Methotrexate, Drug: Triamcinolone AcetonidIntralesional injection of trimethinolone acetonide |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with localized Psoriasis (body surface area<10%)
Key exclusion criteria (1 listed)
- Patient refusal. Generalized psoriasis. Pregnancy. Lactation. Immunocompromised patients . Patients with history of hypersensitivity to methotrexate. Patients with other inflammatory skin disorders. Patients with chronic hepatic, renal , pulmonary ,or haematological disorders. patients on treatment for psoriasis .
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 |
|---|---|---|
| Intralesional Injection of MethotrexateOne psoriatic lesion will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm Another plaque will treated with intralesional ingection of distilled water as controlled plaque. Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment . | Drug | Methotrexate, Triamcinolone Acetonid |
| Triamcinolone AcetonidOne lesion will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 . another plaque will treated with Intralesional injection of distilled water as controed plaque Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment . | Drug | Methotrexate, Triamcinolone Acetonid |
Primary outcome
Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
Time frame: 3 months after treatment
clinical and dermoscopic changes according to psoriasis area severity index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Brief Description of Focus of Study
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.
Gehad Hamdy principal investigator
Gehad Hamdy Abd El-Gaber
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional Injection of Methotrexate and Triamcinolone Acetonid in people with Localized Psoriasis, run by Sohag 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: status not confirmed, as of the sponsor's last update on 7 Jun 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gehad Hamdy (01104269431, gehad011074@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis (time frame: 3 months after treatment). 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 Jun 2022.