Psoriasis Clinical Trial

Light Treatment Effectiveness (LITE) Study

Summary

To compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis

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Full Description

The primary objective of this study is to compare the effectiveness, safety (tolerability), and duration of treatment response at 12 weeks of home versus office-based narrowband ultraviolet B phototherapy for the treatment of psoriasis. Physician Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) will be used to assess effectiveness, safety (tolerability), and duration of treatment response. This is a three year pragmatic, randomized, active comparator effectiveness study.

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Eligibility Criteria

Inclusion Criteria:

Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
Age 12 or older
Plaque or guttate psoriasis predominantly located on trunk and/or extremities, with a physician global assessment average of >1.0, and considered a candidate for phototherapy

Patient is deemed willing and able to comply with either in-office or in-home phototherapy:

In office: Able to travel about 3 times per week for 12 weeks from home, work and/or school during business hours of local site
In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
New or established patient in the practice

Exclusion Criteria:

Patients who are judged unable or unwilling to comply with either in office or in home phototherapy due to time, work, school, or other financial constraints

Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:

How to operate the phototherapy device
How to follow the dosing protocol
Requirement to wear protective eyewear and genital protection equipment
Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0

Patients deemed unsafe to be treated with phototherapy:

History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
History of arsenic intake
Unable to tolerate standing for required duration of treatment due to age or physical function
History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.

Study is for people with:

Psoriasis

Estimated Enrollment:

783

Study ID:

NCT03726489

Recruitment Status:

Completed

Sponsor:

University of Pennsylvania

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There are 38 Locations for this study

See Locations Near You

Total Skin & Beauty Dermatology Center
Birmingham Alabama, 35205, United States
Mayo Clinic Arizona
Scottsdale Arizona, 85259, United States
Johnson Dermatology
Fort Smith Arkansas, 72916, United States
University of Southern California
Los Angeles California, 90033, United States
University of California, San Francisco
San Francisco California, 94143, United States
George Washington University
Washington District of Columbia, 20037, United States
Howard University
Washington District of Columbia, 20059, United States
Northwestern University
Chicago Illinois, 60611, United States
Dawes Fretzin Clinical Research
Indianapolis Indiana, 46256, United States
MD Claiborne and Associates, LLC
New Orleans Louisiana, 70115, United States
MaineHealth/Maine Medical Center
Portland Maine, 04102, United States
Johns Hopkins University
Baltimore Maryland, 21287, United States
DermAssociates LLC
Silver Spring Maryland, 20902, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Dermatology Specialist of Brighton
Brighton Michigan, 48114, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Washington University in St. Louis
Saint Louis Missouri, 63130, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
Heymann, Manders, Green, and Sommer, LLC
Marlton New Jersey, 08053, United States
University of New Mexico
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center
Bronx New York, 10467, United States
HHC Kings County Hospital
Brooklyn New York, 10013, United States
SUNY Downstate Health Sciences University
Brooklyn New York, 11203, United States
Buffalo Medical Group
Buffalo New York, 14221, United States
Infinity Dermatology NYC
Queens New York, 11375, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Ohio State University
Columbus Ohio, 43215, United States
Pennsyvlania Centre For Dermatology
Exton Pennsylvania, 19341, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Temple University
Philadelphia Pennsylvania, 19122, United States
Dermatology Treatment and Research Center
Dallas Texas, 75230, United States
Menter Dermatology Research Institute
Dallas Texas, 75246, United States
West Houston Dermatology
Houston Texas, 77082, United States
University of Utah
Salt Lake City Utah, 84112, United States
University of Vermont & State Agriculture College
Burlington Vermont, 05405, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Frontier Derm Partners CRO, LLC
Mill Creek Washington, 98012, United States
University of Wisconsin
Madison Wisconsin, 53715, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

783

Study ID:

NCT03726489

Recruitment Status:

Completed

Sponsor:


University of Pennsylvania

How clear is this clinincal trial information?

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