Excimer Laser, Serum Markers & Psoriasis

Not Applicable

Withdrawn

• Conditions: Psoriasis
• Interventions: Device: Excimer laser treatment

• Registration Number: NCT02165657
• Lead Sponsor: University Hospitals Cleveland Medical Center

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Excimer laser	Excimer laser treatment	Excimer laser treatment

Primary Outcome Measures

Name	Time	Method
Change in serum inflammatory markers	23 visits (~12 weeks)	Change in CRP, MPO, S100 and Resistin levels from screening to final visit.

Secondary Outcome Measures

Name	Time	Method
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 erythema	23 visits (~12 weeks)	Chromameter Assessment to measure erythema. a\* values are measured with a chromameter. A higher a\* means more erythema.
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.
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center (Concord Site); 🇺🇸 Concord, Ohio, United States