Excimer Laser, Serum Markers & Psoriasis

July 9, 2021 updated by: Margaret Bobonich, NP, University Hospitals Cleveland Medical Center

Effects of UVB Excimer Laser on Serum Inflammatory Markers in Patients With Psoriasis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Concord, Ohio, United States, 44077
        • University Hospitals Cleveland Medical Center (Concord Site)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Excimer laser
Excimer laser treatment
Device: Excimer laser treatment
Excimer laser irradiation twice a week for up to 20 treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum inflammatory markers
Time Frame: 23 visits (~12 weeks)
Change in CRP, MPO, S100 and Resistin levels from screening to final visit.
23 visits (~12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective measure of hyperpigmentation
Time Frame: 23 visits (~12 weeks)
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
Time Frame: 23 visits (~12 weeks)
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
Time Frame: 23 visits (~12 weeks)
PASI will be performed throughout the study to assess response to treatment.
23 visits (~12 weeks)
Improvement in psoriasis based on PGA
Time Frame: 23 visits (~12 weeks)
PGA (Physician Global Assessment) will be performed throughout the study to assess response to treatment.
23 visits (~12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Photomedex

Investigators

  • Principal Investigator: Margaret Bobonich, NP, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-13-33 (Other Identifier: Institutional Review Board (IRB) Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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