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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 : March 22, 2019
Sponsor:
Collaborators:
University of Utah
National Psoriasis Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Psoriasis Psoriatic Plaque Device: Daavlin 7 series 3 panel narrow band phototherapy home units Device: narrow band phototherapy clinic units Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic, randomized, active comparator effectiveness study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Concomitant topical psoriasis treatment [ Time Frame: 24 weeks after randomization ]
    Patient reported topical psoriasis treatment

  3. Patient reported time associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
    patient reported survey

  4. Patient reported costs associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
    patient reported survey

  5. Patient reported time spent on phototherapy [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
    patient reported survey

  6. Phototherapy Dosing [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
    patient or site reported phototherapy dosing

  7. Duration of treatment response during observation period [ Time Frame: 24 weeks after randomization ]
    patient reported response to treatment



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726489


Contacts
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Contact: Suzette Baez Vanderbeek, MPH 215-662-3514 suzette.baezvanderbeek@uphs.upenn.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Khoa Nguyen    714-931-1440    kbn_331@usc.edu   
Principal Investigator: April Armstrong, MD, MPH         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ruizhi Wang    410-502-7546    rwang@jhmi.edu   
Principal Investigator: Noori Kim, MD         
United States, New York
Buffalo Medical Group Recruiting
Buffalo, New York, United States, 14221
Contact: Mary Anne Hitt    716-630-1457    MDiStefano@buffalomedicalgroup.com   
Principal Investigator: Robert E. Kalb, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Adrianne Evans    801-213-0375    adrianne.evans@hsc.utah.edu   
Principal Investigator: Kristina Callis Duffin, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Utah
National Psoriasis Foundation
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Joel M. Gelfand, MD,MSCE University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03726489     History of Changes
Other Study ID Numbers: 831323
PCS-1608-35830 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Insitute )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases