Excimer Light in Psoriasis
Primary Purpose
Psoriasis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Excimer light
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
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)
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
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
Learn more about this trial
Excimer Light in Psoriasis
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