We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Light Treatment Effectiveness (LITE) Study (LITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726489
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : August 17, 2022
Sponsor:
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  ICMJE October 29, 2018
First Posted Date  ICMJE October 31, 2018
Last Update Posted Date August 17, 2022
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light Treatment Effectiveness (LITE) Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pragmatic, randomized, active comparator effectiveness study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Psoriasis
  • Psoriatic Plaque
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2018)
1050
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Suzette Baez Vanderbeek, MPH 215-662-3514 baezs@pennmedicine.upenn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726489
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party University of Pennsylvania
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Pennsylvania
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Utah
  • National Psoriasis Foundation
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Joel M. Gelfand, MD,MSCE University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP