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

Aswan University

Status

Enrolling

Conditions

Psoriatic Conditions

Treatments

Procedure: NB-UVB

Study type

Interventional

Funder types

Other

Identifiers

NCT06712238

Nourhan Salah

Details and patient eligibility

About

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

Full description

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

Enrollment

48 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 4 patient groups

Group A: (Narrow Band Ultraviolet B)

Active Comparator group

Description:

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.

Treatment:

Procedure: NB-UVB

Group B: (Methotrexate )

Active Comparator group

Description:

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.

Treatment:

Procedure: NB-UVB

Group C: (Methotrexate and Narrow Band Ultraviolet B)

Active Comparator group

Description:

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