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Excimer Light in Psoriasis

Primary Purpose

Psoriasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Excimer light
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type of Psoriasis: plaque psoriasis.
  • Less than 10% surface area.

Exclusion Criteria:

  • Erythrodermic psoriasis
  • Pustular psoriasis
  • Topical treatment for psoriasis for the past 2 weeks.
  • Systemic retinoids in the last 2 years.
  • Systemic treatments (including any drugs that affect SP level as Aprepitant) in the last 3 months.
  • Contraindications to excimer light therapy (history of skin malignancy or precancerous conditions like xeroderma pigmentosum or photosensitivity)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Active psoriasis

    Stable psoriasis

    Arm Description

    Outcomes

    Primary Outcome Measures

    Excimer laser efficiency in active and stable psoriasis
    Determine the clinical improvement using Local psoriasis severity index
    Excimer laser efficiency on neurogenic inflammation
    level of affection of the neurogenic inflammation in psoriasis lesions after using Excimer light therapy. Determine substance P and its receptor levels before and after therapy.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2022
    Last Updated
    March 8, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05283876
    Brief Title
    Excimer Light in Psoriasis
    Official Title
    Excimer Light Effect on Neurogenic Inflammation in Developing Versus Stationary Psoriasis Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    October 2022 (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
    The aim of this study is to determine the standard tissue levels of SP and its receptor in lesional skin of psoriasis patients in both developing and stationary stages before and after excimer light therapy.

    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
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active psoriasis
    Arm Type
    Active Comparator
    Arm Title
    Stable psoriasis
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Excimer light
    Intervention Description
    Excimer light sessions
    Primary Outcome Measure Information:
    Title
    Excimer laser efficiency in active and stable psoriasis
    Description
    Determine the clinical improvement using Local psoriasis severity index
    Time Frame
    through study completion, an average of 6 months
    Title
    Excimer laser efficiency on neurogenic inflammation
    Description
    level of affection of the neurogenic inflammation in psoriasis lesions after using Excimer light therapy. Determine substance P and its receptor levels before and after therapy.
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type of Psoriasis: plaque psoriasis. Less than 10% surface area. Exclusion Criteria: Erythrodermic psoriasis Pustular psoriasis Topical treatment for psoriasis for the past 2 weeks. Systemic retinoids in the last 2 years. Systemic treatments (including any drugs that affect SP level as Aprepitant) in the last 3 months. Contraindications to excimer light therapy (history of skin malignancy or precancerous conditions like xeroderma pigmentosum or photosensitivity)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa El-Mesidy, MD
    Phone
    +202 01005139967
    Email
    marwa.elmesidy@kasralainy.edu.eg

    12. IPD Sharing Statement

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    Excimer Light in Psoriasis

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