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Effect Narrow-Band UVB Radiations (UVB)

Primary Purpose

Psoriasis Vulgaris, UVB Phototherapy Burn

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serum Interleukin 17 levels
NB-UVB
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis vulgaris, UVB radiations, Interleukin 17

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • South Valley University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NB-UVB group

Control group

Arm Description

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.

fourty healthy controls without psoriasis , any family history of psoriasis or any dermatological diseases.

Outcomes

Primary Outcome Measures

Primary (main):
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

Secondary Outcome Measures

Secondary (subsidiary)
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.

Full Information

First Posted
December 1, 2022
Last Updated
December 9, 2022
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05647187
Brief Title
Effect Narrow-Band UVB Radiations
Acronym
UVB
Official Title
Effect Narrow-Band UVB Radiation Therapy on Suppression of IL 17 Axis in Psoriatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, UVB Phototherapy Burn
Keywords
Psoriasis vulgaris, UVB radiations, Interleukin 17

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NB-UVB group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
fourty healthy controls without psoriasis , any family history of psoriasis or any dermatological diseases.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Interleukin 17 levels
Other Intervention Name(s)
NB-UVB
Intervention Description
Serum Interleukin 17 levels will be measured pre and post treatment by NB-UVB by performing an enzyme-linked immune sorbent assay (ELISA)
Intervention Type
Radiation
Intervention Name(s)
NB-UVB
Intervention Description
patients will be exposed to narrow band UVB twice weekly for three months
Primary Outcome Measure Information:
Title
Primary (main):
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Secondary (subsidiary)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan M Ibrahim, professor
Organizational Affiliation
South Valley University
Official's Role
Study Director
Facility Information:
Facility Name
South Valley University
City
Qinā
State/Province
Qena
ZIP/Postal Code
83522
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect Narrow-Band UVB Radiations

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