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

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%) .

Study Overview

• Status: Recruiting
• Conditions: Localized Psoriasis
• Intervention / Treatment: Drug: Intralesional Injection of Methotrexate; Drug: Triamcinolone Acetonid

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gehad Hamdy; Phone Number: 01104269431; Email: gehad011074@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University
    • Contact: Gehad Hamdy; Phone Number: 01104269431; Email: gehad011074@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methotrexate; Intralesional injection of methotrexate	Drug: 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 .; 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 .
Active Comparator: Triamcinolone Acetonid; Intralesional injection of trimethinolone acetonide	Drug: 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 .; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis	clinical and dermoscopic changes according to psoriasis area severity index	3 months after treatment

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Gehad Hamdy, Gehad Hamdy Abd El-Gaber

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2022
• Primary Completion (Anticipated): November 21, 2022
• Study Completion (Anticipated): May 21, 2023

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Intralesional Injection ,Methotrexate, localized Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Triamcinolone; Methotrexate
• Other Study ID Numbers: soh-med-22-05-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No