Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients

NCT ID: NCT06712238

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2025-06-10

Brief Summary

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Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales.

The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease

Detailed Description

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The protein expression of gelsolin- which is an actin scavenger controlling cytoskeletal remodeling, cell morphology, differentiation, movement, and apoptosis- has been found to be significantly decreased in several pathological conditions including neurodegenerative diseases, inflammatory disorders, and cancers.

Gelsolin (GSN) is a member of the GSN protein family, the main function of it is to cut and seal actin filaments to regulate the cytoskeleton and participate in a variety of biological functions.

Low serum gelsolin levels are linked to the severity of psoriasis, suggesting that gelsolin may help in assessing the severity of the disease and how it responds to treatment.

Methotrexate (MTX) is the first-choice drug when phototherapy or retinoid treatment are not effective in psoriatic patients.

It is a cytotoxic drug with powerful anti-proliferative and anti-inflammatory effects that has gained prominence in treating inflammatory diseases one of them is psoriasis.

Narrowband (NB) UVB phototherapy is a common line of treatment in psoriasis. It was proven to be more effective than broadband UVB and safer and/or more practicable than psoralen\_UVA in treatment of psoriasis

Conditions

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Psoriatic Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: (Narrow Band Ultraviolet B)

About 12 patients will expose to 24 sessions of Narrow Band Ultraviolet B (NB-UVB) radiation (initial dose of 130 - 400 mJ / cm2 ) selected according to skin for 3 month.

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type PROCEDURE

Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.

Group B: (Methotrexate )

About 12 patients will receive Methotrexate tablets (MTX) in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) for 3 month.

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type PROCEDURE

Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.

Group C: (Methotrexate and Narrow Band Ultraviolet B)

About 12 patients will undergo the treatment by both Methotrexate tablets (MTX) and Narrow Band Ultraviolet B( NB-UVB) radiation.for 3 month.

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type PROCEDURE

Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.

Group D (Control Group)

About 12 patients apparently healthy individuals as control group.and will not take any medication

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type PROCEDURE

Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.

Interventions

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NB-UVB

Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.

Intervention Type PROCEDURE

Other Intervention Names

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Methotrexate

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe plaque psoriasis.
* No restriction of age, race nor occupation.

Exclusion Criteria

* History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
* Pregnancy and lactation.
* Infections.
* Patients with chronic diseases: hepatic disorders, hematologic diseases, chronic renal failure or cancer.
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aswan University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Salah Mohamed

Resident of Dermatology, Venereology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moustafa Adam Ali El Taieb, Professor

Role: STUDY_CHAIR

Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nourhan Salah Mohamed, Resident

Role: CONTACT

+201124152433

Mahmoud Ahmed Ali, Lecturer

Role: CONTACT

+201002364902

Facility Contacts

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Nourhan Salah Mohamed, Resident

Role: primary

+201124152433

Mohamed Amer Ahmed Abdellatif

Role: backup

+201060394083

Other Identifiers

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Nourhan Salah

Identifier Type: -

Identifier Source: org_study_id