NCT05647187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

December 1, 2022

Last Update Submit

December 9, 2022

Conditions

Keywords

Psoriasis vulgarisUVB radiationsInterleukin 17

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary (subsidiary)

    12 weeks

Study Arms (2)

NB-UVB group

ACTIVE COMPARATOR

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 levelsRadiation: NB-UVB

Control group

NO INTERVENTION

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

Interventions

Serum Interleukin 17 levels will be measured pre and post treatment by NB-UVB by performing an enzyme-linked immune sorbent assay (ELISA)

Also known as: NB-UVB
NB-UVB group
NB-UVBRADIATION

patients will be exposed to narrow band UVB twice weekly for three months

NB-UVB group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with psoriasis diagnosed clinically

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Valley University

Qina, Qena Governorate, 83522, Egypt

Location

Study Officials

  • Hassan M Ibrahim, professor

    South Valley University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of dermatology

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 12, 2022

Study Start

January 1, 2020

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations