Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Change in serum inflammatory markers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in serum inflammatory markers
Time Frame: 23 visits (~12 weeks)
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
Secondary Outcomes
- Improvement in Psoriasis based on PASI assessment(23 visits (~12 weeks))
- Objective measure of erythema(23 visits (~12 weeks))
- Objective measure of hyperpigmentation(23 visits (~12 weeks))
- Improvement in psoriasis based on PGA(23 visits (~12 weeks))
Investigators
Margaret Bobonich, NP
Principal Investigator
University Hospitals Cleveland Medical Center