Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis

NCT ID: NCT05408208

Last Updated: 2022-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-21
• Study Completion Date: 2023-05-21

Brief 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%) .

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Methotrexate

Intralesional injection of methotrexate

Group Type: ACTIVE_COMPARATOR

Intralesional Injection of Methotrexate

Intervention Type: DRUG

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 Acetonid

Intervention Type: DRUG

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 .

Triamcinolone Acetonid

Intralesional injection of trimethinolone acetonide

Group Type: ACTIVE_COMPARATOR

Intralesional Injection of Methotrexate

Intervention Type: DRUG

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 Acetonid

Intervention Type: DRUG

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 .

Interventions

Intralesional Injection of Methotrexate

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 .

Intervention Type: DRUG

Triamcinolone Acetonid

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 .

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with localized Psoriasis (body surface area<10%)

Exclusion Criteria

• 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 .

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Gehad Hamdy Abdelgaber

Gehad Hamdy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gehad Hamdy

Role: PRINCIPAL_INVESTIGATOR

Gehad Hamdy Abd El-Gaber

Locations

Sohag University

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Gehad Hamdy

Role: CONTACT

gehad011074@med.sohag.edu.eg

01104269431

Facility Contacts

Gehad Hamdy

Role: primary

gehad011074@med.sohag.edu.eg

01104269431

Other Identifiers

soh-med-22-05-04

Identifier Type: -

Identifier Source: org_study_id