Back to resultsLight Treatment Effectiveness (LITE) Study (LITE)
Primary Purpose
Psoriasis, Psoriatic Plaque
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daavlin 7 series 3 panel narrow band phototherapy home units
narrow band phototherapy clinic units
Sponsored by
About this trial
This is an interventional other trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
- Age 12 or older
- 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
Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
- 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
- In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
- New or established patient in the practice
Exclusion Criteria:
- 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
Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
- How to operate the phototherapy device
- How to follow the dosing protocol
- Requirement to wear protective eyewear and genital protection equipment
- Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
- Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
Patients deemed unsafe to be treated with phototherapy:
- History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
- History of arsenic intake
- Unable to tolerate standing for required duration of treatment due to age or physical function
- History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
- Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Sites / Locations
- Total Skin & Beauty Dermatology Center
- Mayo Clinic Arizona
- Johnson Dermatology
- University of Southern California
- University of California, San Francisco
- George Washington University
- Howard University
- Northwestern University
- Dawes Fretzin Clinical Research
- MD Claiborne and Associates, LLC
- MaineHealth/Maine Medical Center
- Johns Hopkins University
- DermAssociates LLC
- Brigham and Women's Hospital
- Dermatology Specialist of Brighton
- Henry Ford Health System
- Washington University in St. Louis
- Psoriasis Treatment Center of Central New Jersey
- Heymann, Manders, Green, and Sommer, LLC
- University of New Mexico
- Montefiore Medical Center
- HHC Kings County Hospital
- SUNY Downstate Health Sciences University
- Buffalo Medical Group
- Infinity Dermatology NYC
- Wake Forest University Health Sciences
- Ohio State University
- Pennsyvlania Centre For Dermatology
- University of Pennsylvania
- Temple University
- Dermatology Treatment and Research Center
- Menter Dermatology Research Institute
- West Houston Dermatology
- University of Utah
- University of Vermont & State Agriculture College
- University of Virginia
- Frontier Derm Partners CRO, LLC
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Office Based Phototherapy
Home Based Phototherapy
Arm Description
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
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.
Outcomes
Primary Outcome Measures
Treatment Response
measured by Physician Global Assessment (PGA) score of clear/almost clear
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
Secondary Outcome Measures
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
Concomitant topical psoriasis treatment
Patient reported topical psoriasis treatment
Patient reported time associated with travel for phototherapy treatments
patient reported survey
Patient reported costs associated with travel for phototherapy treatments
patient reported survey
Patient reported time spent on phototherapy
patient reported survey
Phototherapy Dosing
patient or site reported phototherapy dosing
Duration of treatment response during observation period
patient reported response to treatment
Full Information
NCT ID
NCT03726489
First Posted
October 29, 2018
Last Updated
June 26, 2023
Sponsor
University of Pennsylvania
Collaborators
University of Utah, National Psoriasis Foundation, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03726489
Brief Title
Light Treatment Effectiveness (LITE) Study
Acronym
LITE
Official Title
A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
University of Utah, National Psoriasis Foundation, Patient-Centered Outcomes Research Institute
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Plaque
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, randomized, active comparator effectiveness study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Office Based Phototherapy
Arm Type
Other
Arm Description
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
Arm Title
Home Based Phototherapy
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Daavlin 7 series 3 panel narrow band phototherapy home units
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
narrow band phototherapy clinic units
Intervention Description
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
Primary Outcome Measure Information:
Title
Treatment Response
Description
measured by Physician Global Assessment (PGA) score of clear/almost clear
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Impact of dermatological disease on quality of life
Description
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
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
Body Surface Area multiplied by Physician Global Assessment
Description
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
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Concomitant topical psoriasis treatment
Description
Patient reported topical psoriasis treatment
Time Frame
24 weeks after randomization
Title
Patient reported time associated with travel for phototherapy treatments
Description
patient reported survey
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Patient reported costs associated with travel for phototherapy treatments
Description
patient reported survey
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Patient reported time spent on phototherapy
Description
patient reported survey
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Phototherapy Dosing
Description
patient or site reported phototherapy dosing
Time Frame
12 weeks after randomization or earlier at discontinuation of phototherapy
Title
Duration of treatment response during observation period
Description
patient reported response to treatment
Time Frame
24 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)
Age 12 or older
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
Patient is deemed willing and able to comply with either in-office or in-home phototherapy:
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
In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions
New or established patient in the practice
Exclusion Criteria:
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
Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:
How to operate the phototherapy device
How to follow the dosing protocol
Requirement to wear protective eyewear and genital protection equipment
Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit
Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0
Patients deemed unsafe to be treated with phototherapy:
History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
History of arsenic intake
Unable to tolerate standing for required duration of treatment due to age or physical function
History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy
Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel M. Gelfand, MD,MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Howard University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dawes Fretzin Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
MD Claiborne and Associates, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
MaineHealth/Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
DermAssociates LLC
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dermatology Specialist of Brighton
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Heymann, Manders, Green, and Sommer, LLC
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
HHC Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
SUNY Downstate Health Sciences University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Buffalo Medical Group
City
Buffalo
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Infinity Dermatology NYC
City
Queens
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Pennsyvlania Centre For Dermatology
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
Dermatology Treatment and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Menter Dermatology Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
West Houston Dermatology
City
Houston
State/Province
Texas
ZIP/Postal Code
77082
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Vermont & State Agriculture College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Frontier Derm Partners CRO, LLC
City
Mill Creek
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Light Treatment Effectiveness (LITE) Study
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