Light Treatment Effectiveness (LITE) Study (LITE)

A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriatic Plaque
• Intervention / Treatment: Device: narrow band phototherapy clinic units; Device: Daavlin 7 series 3 panel narrow band phototherapy home units

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.

• Study Type: Interventional
• Enrollment (Actual): 783
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzette Baez Vanderbeek, MPH; Phone Number: 215-662-3514; Email: baezs@pennmedicine.upenn.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Office Based Phototherapy; Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.	Device: narrow band phototherapy clinic units; Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
Active Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Response	measured by Physician Global Assessment (PGA) score of clear/almost clear	12 weeks after randomization or earlier at discontinuation of phototherapy
Impact of dermatological disease on quality of life	Dermatology Life Quality Index (DLQI) score of ≤5 which corresponds to no to small impact of dermatologic disease on quality of life. DLQI is a 10 item survey that asks patients questions about their health related quality of life on a 0-3 scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired	12 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Surface Area multiplied by Physician Global Assessment	Physician Global Assessment multiplied by Body Surface Area (BSA). BSA is a measure that asks the physician or his or her designee to assess the body surface area affected by psoriasis using the handprint method in which the palm of the entire hand approximates 1% of the body surface area. To do this, the patient's handprint, including the entire area of the palm and all 5 digits with the fingers close together but not overlapping, is used as a guide to estimate 1% of the BSA	12 weeks after randomization or earlier at discontinuation of phototherapy
Concomitant topical psoriasis treatment	Patient reported topical psoriasis treatment	24 weeks after randomization
Patient reported time associated with travel for phototherapy treatments	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Patient reported costs associated with travel for phototherapy treatments	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Patient reported time spent on phototherapy	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Phototherapy Dosing	patient or site reported phototherapy dosing	12 weeks after randomization or earlier at discontinuation of phototherapy
Duration of treatment response during observation period	patient reported response to treatment	24 weeks after randomization

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Patient-Centered Outcomes Research Institute; University of Utah; National Psoriasis Foundation
• Investigators: Principal Investigator: Joel M. Gelfand, MD,MSCE, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 831323; PCS-1608-35830 (Other Grant/Funding Number: Patient-Centered Outcomes Research Insitute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No