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

November 26, 2024 updated by: Nourhan Salah Mohamed, Aswan University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: NB-UVB
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
Other Names:
  • Methotrexate
Active Comparator: 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.
Procedure: NB-UVB
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
Other Names:
  • Methotrexate
Active Comparator: 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.
Procedure: NB-UVB
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
Other Names:
  • Methotrexate
Active Comparator: Group D (Control Group)
About 12 patients apparently healthy individuals as control group.and will not take any medication
Procedure: NB-UVB
Comparison between serum Level of Gelsolin (GSN) in Psoriatic Patients and controls and correlate its level with PASI.
Other Names:
  • Methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of the Psoriasis
Time Frame: 3 months
About 36 patients suffering from Psoriasis and will be treated by exposing to Narrow band ultraviolet B radiation (initial dose of 130 - 400 mJ / cm2 selected according to skin phototype and gradual increase after each session ), and taking Methotrexate tablets in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) .
3 months
Serum Gelsolin Evaluation
Time Frame: 3 Months
Evaluation the Serum Gelsolin level in Psoriatic Patients after treatment by Narrow band ultraviolet B and taking Methotrexate tablets.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University

Investigators

  • Study Chair: Moustafa Adam Ali El Taieb, Professor, Dermatology, Venereology and Andrology.Faculty of Medicine, Aswan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 10, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nourhan Salah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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