Back to resultsExcimer Laser, Serum Markers & Psoriasis
Primary Purpose
Psoriasis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Excimer laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Excimer laser, UVB, Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Age 18 years and older
- Male or female with diagnosis of psoriasis
- Psoriasis involvement of 5-15% BSA
- Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
- Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
- Fitzpatrick Skin Types I-VI
Exclusion Criteria:
- Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
- Any suspicion that the psoriasis is of the photosensitive variant.
- Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
Sites / Locations
- University Hospitals Cleveland Medical Center (Concord Site)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Excimer laser
Arm Description
Excimer laser treatment
Outcomes
Primary Outcome Measures
Change in serum inflammatory markers
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
Secondary Outcome Measures
Objective measure of hyperpigmentation
Chromameter Assessment to measure hyperpigmentation. L* values are measured with a chromameter. A lower L* means more hyperpigmentation.
Objective measure of erythema
Chromameter Assessment to measure erythema. a* values are measured with a chromameter. A higher a* means more erythema.
Improvement in Psoriasis based on PASI assessment
PASI will be performed throughout the study to assess response to treatment.
Improvement in psoriasis based on PGA
PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.
Full Information
NCT ID
NCT02165657
First Posted
June 13, 2014
Last Updated
July 9, 2021
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Photomedex
1. Study Identification
Unique Protocol Identification Number
NCT02165657
Brief Title
Excimer Laser, Serum Markers & Psoriasis
Official Title
Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants into trial
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Photomedex
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall aims for this study are to determine whether UVB excimer laser treatment of psoriasis affects serum inflammatory markers, and to assess hyperpigmentation and erythema with excimer laser treatment.
The investigators hypothesize that treatment of psoriasis with UVB delivered via 308 nm excimer laser will decrease the levels of serum inflammatory markers. The investigators hypothesize that treatment will decrease plaque erythema and will result in minimal hyperpigmentation.
Detailed Description
Subjects will undergo Excimer treatment twice a week until they reach a PASI 75 improvement, or until they reach the maximum of 20 total treatments. A blood draw to assess serum inflammatory markers will be performed at the screening visit and final visit. Chromameter assessment, photographs, PASI and PGA (Physician Global Assessment) will be performed throughout the study to monitor psoriasis improvement, hyperpigmentation and erythema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Excimer laser, UVB, Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excimer laser
Arm Type
Experimental
Arm Description
Excimer laser treatment
Intervention Type
Device
Intervention Name(s)
Excimer laser treatment
Intervention Description
Excimer laser irradiation twice a week for up to 20 treatments.
Primary Outcome Measure Information:
Title
Change in serum inflammatory markers
Description
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
Time Frame
23 visits (~12 weeks)
Secondary Outcome Measure Information:
Title
Objective measure of hyperpigmentation
Description
Chromameter Assessment to measure hyperpigmentation. L* values are measured with a chromameter. A lower L* means more hyperpigmentation.
Time Frame
23 visits (~12 weeks)
Title
Objective measure of erythema
Description
Chromameter Assessment to measure erythema. a* values are measured with a chromameter. A higher a* means more erythema.
Time Frame
23 visits (~12 weeks)
Title
Improvement in Psoriasis based on PASI assessment
Description
PASI will be performed throughout the study to assess response to treatment.
Time Frame
23 visits (~12 weeks)
Title
Improvement in psoriasis based on PGA
Description
PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.
Time Frame
23 visits (~12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 years and older
Male or female with diagnosis of psoriasis
Psoriasis involvement of 5-15% BSA
Has been off systemic psoriasis therapies (e.g. retinoids, methotrexate, biologic agents, etc) for at least 4 weeks
Has been off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks
Fitzpatrick Skin Types I-VI
Exclusion Criteria:
Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria)
Any suspicion that the psoriasis is of the photosensitive variant.
Any medical condition that could be aggravated or may cause extreme discomfort during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Bobonich, NP
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center (Concord Site)
City
Concord
State/Province
Ohio
ZIP/Postal Code
44077
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Excimer Laser, Serum Markers & Psoriasis
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