Effect Narrow-Band UVB Radiations (UVB)

December 9, 2022 updated by: Hassan Mohammed Ibrahim, South Valley University

Effect Narrow-Band UVB Radiation Therapy on Suppression of IL 17 Axis in Psoriatic Patients

Narrow-band UVR affects Interleukin 17 which has a major role in the pathogenesis of psoriasis Vulgaris. the aim of this study to evaluate the serum levels of Interleukin 17 in psoriatic patients and compare with the levels in healthy controls & evaluate the effect of narrow-band ultraviolet B (NB-UVB) on the serum of Interleukin 17 and the treatment of psoriasis Vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nowadays Interleukin 17 has a major role in the pathogenesis of psoriasis Vulgaris.

the aim of this study to evaluate the serum levels of Interleukin 17 in psoriatic patients and compare them with the levels in healthy controls & evaluate the effect of narrow-band ultraviolet B (NB-UVB) on the serum of Interleukin 17 and the treatment of psoriasis Vulgaris. This prospective randomized clinical trial was carried out in Dermatology Department, South Valley University Hospitals included from September 2020 to August 2021, enrolled 40 psoriatic patients and 40 controls. The study was submitted for approval from the Scientific and Ethical Committees and coded as ( SVU.MED.DVA021, Code 1, N 76). Forty patients were treated with NB-UVB by starting the dose from 0.5 mJ/cm2 for all cases (Skin phototypes III or IV). The dosage is subsequently increased by 20 % per session. Sessions were given three times weekly on non-consecutive days for 12 weeks (three months). Serum Interleukin 17 levels were measured pre-and post-12 weeks narrow-band ultraviolet B by performing an enzyme-linked immune sorbent assay (ELISA). Main outcome and Measures: Improvement of psoriasis Severity Index score after 12 weeks narrow- Band UVR treatment and serum-decreased IL17 by performing an enzyme-linked immune sorbent assay (ELISA).

Study Type

Interventional

Enrollment (Actual)

80

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 Locations

  • Egypt
    • Qena
      • Qinā, Qena, Egypt, 83522
        • South Valley University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with psoriasis diagnosed clinically

Exclusion Criteria:

  • Patient with history of skin cancer. Patient with history of photosensitivity. Patient receiving immune suppressive drugs .

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NB-UVB group
fourty patients will be treated with NB-UVB. The initial radiation dose was determined according to the patient's skin type; initial dose will be increased by 20% per session. Sessions will be given three times weekly with 48 hours apart for three months.
Diagnostic test: Serum Interleukin 17 levels
Serum Interleukin 17 levels will be measured pre and post treatment by NB-UVB by performing an enzyme-linked immune sorbent assay (ELISA)
Other Names:
  • NB-UVB
Radiation: NB-UVB
patients will be exposed to narrow band UVB twice weekly for three months
No Intervention: Control group
fourty healthy controls without psoriasis , any family history of psoriasis or any dermatological diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary (main):
Time Frame: 12 weeks
To evaluate the clinical efficacy of narrow-band ultraviolet B (NB-UVB) in treatment of psoriasis vulgaris , evaluate serum levels of Interleukin 17 in psoriatic patients and compare them with levels in healthy controls
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary (subsidiary)
Time Frame: 12 weeks
Response to treatment will be evaluated by photographing the patients and calculating psoriasis area and severity index (PASI) score at the baseline before starting the treatment and monthly after starting the treatment.
12 weeks

Collaborators and Investigators

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

Sponsor

South Valley University

Investigators

  • Study Director: Hassan M Ibrahim, professor, South Valley 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)

January 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Estimate)

December 12, 2022

Study Record Updates

Last Update Posted (Estimate)

December 12, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU.MED.DVA021, Code 1, N76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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