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| ID | Type | Description | Link |
|---|---|---|---|
| 06-13-33 | Other Identifier | Institutional Review Board (IRB) Number |
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Unable to recruit participants into trial
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| Name | Class |
|---|---|
| Photomedex | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excimer laser | Experimental | Excimer laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excimer laser treatment | Device | Excimer laser irradiation twice a week for up to 20 treatments. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum inflammatory markers | Change in CRP, MPO, S100 and Resistin levels from screening to final visit. | 23 visits (~12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective measure of hyperpigmentation | Chromameter Assessment to measure hyperpigmentation. L* values are measured with a chromameter. A lower L* means more hyperpigmentation. | 23 visits (~12 weeks) |
| Objective measure of erythema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Bobonich, NP | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center (Concord Site) | Concord | Ohio | 44077 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2016 | Jun 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Chromameter Assessment to measure erythema. a* values are measured with a chromameter. A higher a* means more erythema.
| 23 visits (~12 weeks) |
| Improvement in Psoriasis based on PASI assessment | PASI will be performed throughout the study to assess response to treatment. | 23 visits (~12 weeks) |
| Improvement in psoriasis based on PGA | PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment. | 23 visits (~12 weeks) |