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Effect Narrow-Band UVB Radiations

Sponsor
South Valley University (Other)
Overall Status
Completed
CT.gov ID
NCT05647187
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
21
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serum Interleukin 17 levels
  • Radiation: NB-UVB
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect Narrow-Band UVB Radiation Therapy on Suppression of IL 17 Axis in Psoriatic Patients
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jul 1, 2021
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Primary (main): [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

    Secondary Outcome Measures

    1. Secondary (subsidiary) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Valley University Qinā Qena Egypt 83522

    Sponsors and Collaborators

    • South Valley University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hassan Mohammed Ibrahim, Associate professor of dermatology, South Valley University
    ClinicalTrials.gov Identifier:
    NCT05647187
    Other Study ID Numbers:
    • SVU.MED.DVA021, Code 1, N76
    First Posted:
    Dec 12, 2022
    Last Update Posted:
    Dec 12, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hassan Mohammed Ibrahim, Associate professor of dermatology, South Valley University
    Psoriasis vulgaris
    UVB radiations
    Interleukin 17
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Dec 12, 2022