Light Treatment Effectiveness (LITE) Study (LITE)

• ClinicalTrials.gov Identifier: NCT03726489
• Recruitment Status: Completed
• First Posted: October 31, 2018
• Last Update Posted: March 20, 2024
• Sponsor: University of Pennsylvania
• Collaborators: University of Utah; National Psoriasis Foundation; Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): University of Pennsylvania

Tracking Information

• First Submitted Date: October 29, 2018
• First Posted Date: October 31, 2018
• Last Update Posted Date: March 20, 2024
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 30, 2018)

• Treatment Response [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  measured by Physician Global Assessment (PGA) score of clear/almost clear
• Impact of dermatological disease on quality of life [ Time Frame: 12 weeks after randomization ]
  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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 30, 2018)

• Body Surface Area multiplied by Physician Global Assessment [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  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
• Concomitant topical psoriasis treatment [ Time Frame: 24 weeks after randomization ]
  Patient reported topical psoriasis treatment
• Patient reported time associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  patient reported survey
• Patient reported costs associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  patient reported survey
• Patient reported time spent on phototherapy [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  patient reported survey
• Phototherapy Dosing [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
  patient or site reported phototherapy dosing
• Duration of treatment response during observation period [ Time Frame: 24 weeks after randomization ]
  patient reported response to treatment

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Pragmatic, randomized, active comparator effectiveness study

Masking: None (Open Label)
Primary Purpose: Other

Condition

• Psoriasis
• Psoriatic Plaque

Intervention

• 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
• Device: narrow band phototherapy clinic units
  Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

Study Arms

• Office Based Phototherapy
  Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
  Intervention: Device: narrow band phototherapy clinic units
• 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.
  Intervention: Device: Daavlin 7 series 3 panel narrow band phototherapy home units

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 19, 2024): 783
• Original Estimated Enrollment (submitted: October 30, 2018): 1050
• Actual Study Completion Date: December 30, 2023
• Actual Primary Completion Date: October 31, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03726489
• Other Study ID Numbers: 831323; PCS-1608-35830 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Insitute )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Pennsylvania
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pennsylvania
• Original Study Sponsor: Same as current

Collaborators

• University of Utah
• National Psoriasis Foundation
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Joel M. Gelfand, MD,MSCE; University of Pennsylvania

• PRS Account: University of Pennsylvania
• Verification Date: March 2024