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Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
skin biopsy before and after NB-UVB phototherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriasis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with psoriasis (adults and children above 12years)
  • Both sexes.
  • New cases or cases not receiving any treatment for at least 3 months ago.

Exclusion Criteria:

  • Any contraindication to phototherapy treatment (e.g. Photosensitizing creams or medications, past skin cancer, especially melanoma, etc...)
  • Erythrodermic and pustular psoriasis.
  • History of autoimmune diseases or other systemic diseases (e.g. Alzheimer's disease, fibromyalgia, cystic fibrosis)

Sites / Locations

  • Maha Fathy ElmasryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

psoriasis patients

controls

Arm Description

Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.

Tissue levels of resolvin D1 in controls

Outcomes

Primary Outcome Measures

Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2018
Last Updated
March 23, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03483311
Brief Title
Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy
Official Title
Estimation of Tissue Level of Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy: a Case-control Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
• Assessment of tissue level of resolvin D1 in psoriasis in comparison to its level in healthy controls in order to verify its role in the pathogenesis of psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
psoriasis patients
Arm Type
Experimental
Arm Description
Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.
Arm Title
controls
Arm Type
Experimental
Arm Description
Tissue levels of resolvin D1 in controls
Intervention Type
Other
Intervention Name(s)
skin biopsy before and after NB-UVB phototherapy
Intervention Description
skin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1
Primary Outcome Measure Information:
Title
Tissue levels of resolvin D1 in psoriatic patients before and after NB-UVB.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with psoriasis (adults and children above 12years) Both sexes. New cases or cases not receiving any treatment for at least 3 months ago. Exclusion Criteria: Any contraindication to phototherapy treatment (e.g. Photosensitizing creams or medications, past skin cancer, especially melanoma, etc...) Erythrodermic and pustular psoriasis. History of autoimmune diseases or other systemic diseases (e.g. Alzheimer's disease, fibromyalgia, cystic fibrosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Fathy Elmasry, MD
Phone
01222633740
Email
mahafathy1214@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Elmasry
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maha Fathy Elmasry
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Fathy Elmasry, MD
Phone
01222633740
Email
mahafathy1214@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586174
Citation
Elmasry MF, Hassan E, Rashed LA, Abdel Halim DM. Role of resolvin D1 in psoriasis before and after narrowband ultraviolet B phototherapy: A case-control study. Dermatol Ther. 2021 Mar;34(2):e14879. doi: 10.1111/dth.14879. Epub 2021 Feb 21.
Results Reference
derived

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Resolvin D1 in Psoriasis Before and After Narrowband UVB Phototherapy

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