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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03526705
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : July 23, 2019
Information provided by (Responsible Party):
Dina Saadi, Cairo University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Psoriasis Device: NB-UVB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of NB-UVB on Interleukin-36 Levels in Psoriasis Lesional Skin
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: nb-uvb
psoriasis patients will receive 26 sessions of nb-uvb phototherapy
Device: NB-UVB

Primary Outcome Measures :
  1. changes in Il-36 levels in 25 psoriasis patients after 26 sessions of NB-UVB [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. changes in cathepsin G levels in 25 psoriasis patients after 26 sessions of NB-UVB psoriasis [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Dina Saadi, Lecturer, Cairo University Identifier: NCT03526705    
Other Study ID Numbers: Kapu1
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases