Excimer Laser, Serum Markers & Psoriasis

NCT ID: NCT02165657

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Excimer laser

Excimer laser treatment

Group Type EXPERIMENTAL

Excimer laser treatment

Intervention Type DEVICE

Excimer laser irradiation twice a week for up to 20 treatments.

Interventions

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Excimer laser treatment

Excimer laser irradiation twice a week for up to 20 treatments.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Photomedex

UNKNOWN

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Margaret Bobonich, NP

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Bobonich, NP

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals Cleveland Medical Center (Concord Site)

Concord, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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06-13-33

Identifier Type: OTHER

Identifier Source: secondary_id

06-13-33

Identifier Type: -

Identifier Source: org_study_id

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