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

Primary Purpose

Localized Psoriasis

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Intralesional Injection of Methotrexate

Triamcinolone Acetonid

About this trial

This is an interventional treatment trial for Localized Psoriasis focused on measuring Intralesional Injection ,Methotrexate, localized Psoriasis

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

Sohag UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Methotrexate

Triamcinolone Acetonid

Arm Description

Intralesional injection of methotrexate

Intralesional injection of trimethinolone acetonide

Outcomes

Primary Outcome Measures

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

clinical and dermoscopic changes according to psoriasis area severity index

Secondary Outcome Measures

Full Information

NCT ID

NCT05408208

First Posted

May 22, 2022

Last Updated

June 1, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05408208

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 21, 2022 (Actual)

Primary Completion Date

November 21, 2022 (Anticipated)

Study Completion Date

May 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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%) .

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Localized Psoriasis

Keywords

Intralesional Injection ,Methotrexate, localized Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Methotrexate

Arm Type

Active Comparator

Arm Description

Intralesional injection of methotrexate

Arm Title

Triamcinolone Acetonid

Arm Type

Active Comparator

Arm Description

Intralesional injection of trimethinolone acetonide

Intervention Type

Drug

Intervention Name(s)

Intralesional Injection of Methotrexate

Intervention Description

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

Intervention Name(s)

Triamcinolone Acetonid

Intervention Description

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 .

Primary Outcome Measure Information:

Title

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

Description

clinical and dermoscopic changes according to psoriasis area severity index

Time Frame

3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gehad Hamdy

Phone

01104269431

gehad011074@med.sohag.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gehad Hamdy

Organizational Affiliation

Gehad Hamdy Abd El-Gaber

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sohag University

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gehad Hamdy

Phone

01104269431

gehad011074@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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