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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05647187
Other study ID # SVU.MED.DVA021, Code 1, N76
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date October 1, 2021

Study information

Verified date December 2022
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)
Radiation:
NB-UVB
patients will be exposed to narrow band UVB twice weekly for three months

Locations

Country Name City State
Egypt South Valley University Qina Qena

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 weeks
Secondary 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. 12 weeks
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