Psoriasis
Conditions
Keywords
Excimer laser, UVB, Psoriasis
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.
Interventions
DEVICEExcimer laser treatment
Excimer laser irradiation twice a week for up to 20 treatments.
Sponsors
Photomedex
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum inflammatory markers | 23 visits (~12 weeks) | Change in CRP, MPO, S100 and Resistin levels from screening to final visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Psoriasis based on PASI assessment | 23 visits (~12 weeks) | PASI will be performed throughout the study to assess response to treatment. |
| Objective measure of hyperpigmentation | 23 visits (~12 weeks) | Chromameter Assessment to measure hyperpigmentation. L\* values are measured with a chromameter. A lower L\* means more hyperpigmentation. |
| Objective measure of erythema | 23 visits (~12 weeks) | Chromameter Assessment to measure erythema. a\* values are measured with a chromameter. A higher a\* means more erythema. |
| Improvement in psoriasis based on PGA | 23 visits (~12 weeks) | PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment. |
Countries
United States
Outcome results
None listed