NCT02165657

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

3.5 years

First QC Date

June 13, 2014

Last Update Submit

July 9, 2021

Conditions

Keywords

Excimer laserUVBPsoriasis

Outcome Measures

Primary Outcomes (1)

  • Change in serum inflammatory markers

    Change in CRP, MPO, S100 and Resistin levels from screening to final visit.

    23 visits (~12 weeks)

Secondary Outcomes (4)

  • Objective measure of hyperpigmentation

    23 visits (~12 weeks)

  • Objective measure of erythema

    23 visits (~12 weeks)

  • Improvement in Psoriasis based on PASI assessment

    23 visits (~12 weeks)

  • Improvement in psoriasis based on PGA

    23 visits (~12 weeks)

Study Arms (1)

Excimer laser

EXPERIMENTAL

Excimer laser treatment

Device: Excimer laser treatment

Interventions

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

Excimer laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center (Concord Site)

Concord, Ohio, 44077, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Margaret Bobonich, NP

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 17, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations