Study Results
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View full resultsBasic Information
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COMPLETED
NA
783 participants
INTERVENTIONAL
2019-03-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Office Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
narrow band phototherapy clinic units
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
Home Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a home setting via Daavlin 7 series 3 panel narrow band phototherapy home units.
Daavlin 7 series 3 panel narrow band phototherapy home units
Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors
Interventions
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Daavlin 7 series 3 panel narrow band phototherapy home units
Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21" wide, 74.5" tall, and 23.5"). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors
narrow band phototherapy clinic units
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
Eligibility Criteria
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Inclusion Criteria
2. Age 12 or older
3. 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
4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
1. 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
2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
5. New or established patient in the practice
Exclusion Criteria
2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
1. How to operate the phototherapy device
2. How to follow the dosing protocol
3. Requirement to wear protective eyewear and genital protection equipment
3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
5. Patients deemed unsafe to be treated with phototherapy:
1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
2. History of arsenic intake
3. Unable to tolerate standing for required duration of treatment due to age or physical function
4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
12 Years
ALL
No
Sponsors
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University of Utah
OTHER
National Psoriasis Foundation
OTHER
Patient-Centered Outcomes Research Institute
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Joel M. Gelfand, MD,MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
University of Southern California
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
MD Claiborne and Associates, LLC
New Orleans, Louisiana, United States
MaineHealth/Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
DermAssociates LLC
Silver Spring, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dermatology Specialist of Brighton
Brighton, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Heymann, Manders, Green, and Sommer, LLC
Marlton, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
HHC Kings County Hospital
Brooklyn, New York, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, United States
Buffalo Medical Group
Buffalo, New York, United States
Infinity Dermatology NYC
Queens, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Pennsyvlania Centre For Dermatology
Exton, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Dermatology Treatment and Research Center
Dallas, Texas, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
West Houston Dermatology
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont & State Agriculture College
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Gelfand JM, Armstrong AW, Lim HW, Feldman SR, Johnson SM, Claiborne WCC, Kalb RE, Jakus J, Mangold AR, Flowers RH, Bhutani T, Durkin JR, Bagel J, Fretzin S, Sheehan MP, Krell J, Reeder M, Kaffenberger J, Kartono F, Takeshita J, Bridges AM, Fielding E, Nehal US, Schaecher KL, Howard LM, Eakin GS, Baez S, Bishop BE, Fitzsimmons RC Jr, Papadopoulos M, Song WB, Linn KA, Hubbard RA, Shin DB, Callis Duffin K. Home- vs Office-Based Narrowband UV-B Phototherapy for Patients With Psoriasis: The LITE Randomized Clinical Trial. JAMA Dermatol. 2024 Dec 1;160(12):1320-1328. doi: 10.1001/jamadermatol.2024.3897.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PCS-1608-35830
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
831323
Identifier Type: -
Identifier Source: org_study_id
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