The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis

The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin

Psoriasis is an immune-mediated skin disease that affects 1-2 % of the population. Several cytokines have been found to be involved in the complex pathogenesis of this disease. Il- 36 is one of the cytokines sharing in psoriasis pathogenesis, as its levels are elevated in psoriatic plaques. Cathepsin G is known to activate Il- 36 and promote inflammation in psoriasis.NB-UVB is one of the important treatment modalities for psoriasis.

The aim of this study is to detect the effect of NB-UVB on the lesional levels of IL-36 in psoriasis.

Study Overview

• Status: Unknown
• Conditions: Psoriasis
• Intervention / Treatment: Device: NB-UVB

Detailed Description

25 psoriasis patients will receive 26 sessions of phototherapy (NB-UVB). Patients will receive 3 sessions per week. Tissue levels of IL-36 and Cathepsin G will be assessed in skin lesions before starting treatment and after completing the 26 sessions.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with psoriasis vulgaris of both sexes
• Age between 18 and 60 years old.

Exclusion Criteria:

• Pregnant females
• Patients receiving systemic treatment or topical treatment for psoriasis within the past two months.
• Patients having other dermatological diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nb-uvb; psoriasis patients will receive 26 sessions of nb-uvb phototherapy	Device: NB-UVB; Phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB	primary	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis	secondary	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2019
• Primary Completion (Anticipated): January 15, 2020
• Study Completion (Anticipated): January 15, 2020

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Kapu1

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