Clinical trial NCT03726489: Light Treatment Effectiveness (LITE) Study
Official title: A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Psoriatic Plaque
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Utah
name: National Psoriasis Foundation
name: Patient-Centered Outcomes Research Institute
First posted: 2018-10-31
Enrollment: 783
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, randomized, active comparator effectiveness study
Primary purpose: OTHER

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
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:

1. 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
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.

Primary outcomes:
measure: Physician Global Assessment (PGA) Score of Clear/Almost Clear
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary outcomes:
measure: Total Number of Phototherapy Treatments Received
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Cumulative Dose of Phototherapy Received
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Concomitant Topical Psoriasis Treatment
timeFrame: week 12 and week 24 after randomization
measure: Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
timeFrame: week 12 and week 24 after randomization
measure: Patient-reported Time Spent on Phototherapy Per Treatment
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Patient Reported Costs Associated With Travel for Phototherapy Treatments
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Patient Reported Time Associated With Travel for Phototherapy Treatments
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: DLQI (0-1)
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Physician Global Assessment Times Body Surface Area (PGAxBSA)
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: PGA x BSA 75%
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: PGA x BSA 90%
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Duration of Treatment Response During Observation Period
timeFrame: 24 weeks after randomization
measure: Patients Receiving at Least 80% of Treatments
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Other outcomes:
measure: Safety Analysis of Skin Related Events
timeFrame: Week 12
measure: Physician Global Assessment (PGA) Score of Clear/Almost Clear ("As Treated" Analysis)
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Impact of Dermatological Disease on Quality of Life ("As Treated" Analysis)
timeFrame: 12 weeks after randomization or earlier at discontinuation of phototherapy
measure: Dichotomized DLQI Beyond Week 12
timeFrame: From Week 12 to Week 24
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: New Orleans
country: United States
facility: MD Claiborne and Associates, LLC
state: Louisiana
city: Portland
country: United States
facility: MaineHealth/Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Silver Spring
country: United States
facility: DermAssociates LLC
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Brighton
country: United States
facility: Dermatology Specialist of Brighton
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Marlton
country: United States
facility: Heymann, Manders, Green, and Sommer, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: HHC Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: Buffalo
country: United States
facility: Buffalo Medical Group
state: New York
city: Queens
country: United States
facility: Infinity Dermatology NYC
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Exton
country: United States
facility: Pennsyvlania Centre For Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: West Houston Dermatology
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: University of Vermont & State Agriculture College
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Mill Creek
country: United States
facility: Frontier Derm Partners CRO, LLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Joel M. Gelfand, MD,MSCE
role: PRINCIPAL_INVESTIGATOR
References: