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

• Sponsor: Sohag University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05408208
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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%) .

Condition or Disease	Intervention/Treatment	Phase
Localized Psoriasis	Drug: Intralesional Injection of Methotrexate; Drug: Triamcinolone Acetonid	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis
• Actual Study Start Date: May 21, 2022
• Anticipated Primary Completion Date: Nov 21, 2022
• Anticipated Study Completion Date: May 21, 2023

Arms and Interventions

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 .

Outcome Measures

Primary Outcome Measures

1. Efficacy Of Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis [3 months after treatment]

   clinical and dermoscopic changes according to psoriasis area severity index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt

Sponsors and Collaborators

• Sohag University

Investigators

• Principal Investigator: Gehad Hamdy, Gehad Hamdy Abd El-Gaber

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gehad Hamdy Abdelgaber, Gehad Hamdy, Sohag University
• ClinicalTrials.gov Identifier: NCT05408208
• Other Study ID Numbers: soh-med-22-05-04
• First Posted: Jun 7, 2022
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gehad Hamdy Abdelgaber, Gehad Hamdy, Sohag University: Intralesional Injection ,Methotrexate, localized Psoriasis
• Additional relevant MeSH terms: Psoriasis; Triamcinolone; Methotrexate

Study Results

No Results Posted as of Jun 7, 2022