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

Study Purpose

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%) .

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 15 Years - 65 Years
Gender All
More Inclusion & Exclusion 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 .

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05408208
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sohag University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gehad Hamdy
Principal Investigator Affiliation Gehad Hamdy Abd El-Gaber
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Localized Psoriasis
Additional Details

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 .

Arms & Interventions

Arms

Active Comparator: Methotrexate

Intralesional injection of methotrexate

Active Comparator: Triamcinolone Acetonid

Intralesional injection of trimethinolone acetonide

Interventions

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 .

Contact a Trial Team

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International Sites

Sohag University, Sohag, Egypt

Status

Recruiting

Address

Sohag University

Sohag, ,

Site Contact

Gehad Hamdy

gehad011074@med.sohag.edu.eg

01104269431

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