Light Treatment Effectiveness (LITE) Study (LITE)

March 19, 2024 updated by: University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
783

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 weeks after randomization or earlier at discontinuation of phototherapy
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
12 weeks after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 weeks after randomization or earlier at discontinuation of phototherapy
Concomitant topical psoriasis treatment
Time Frame: 24 weeks after randomization
Patient reported topical psoriasis treatment
24 weeks after randomization
Patient reported time associated with travel for phototherapy treatments
Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
patient reported survey
12 weeks after randomization or earlier at discontinuation of phototherapy
Patient reported costs associated with travel for phototherapy treatments
Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
patient reported survey
12 weeks after randomization or earlier at discontinuation of phototherapy
Patient reported time spent on phototherapy
Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
patient reported survey
12 weeks after randomization or earlier at discontinuation of phototherapy
Phototherapy Dosing
Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
patient or site reported phototherapy dosing
12 weeks after randomization or earlier at discontinuation of phototherapy
Duration of treatment response during observation period
Time Frame: 24 weeks after randomization
patient reported response to treatment
24 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
University of Utah
National Psoriasis Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joel M. Gelfand, MD,MSCE, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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