Light Treatment Effectiveness (LITE) Study

Not Applicable

Completed

• Conditions: Psoriasis; Psoriatic Plaque
• Interventions: Device: Daavlin 7 series 3 panel narrow band phototherapy home units; Device: narrow band phototherapy clinic units

• Registration Number: NCT03726489
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2019-03-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 783

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Physician Global Assessment (PGA) Score of Clear/Almost Clear	12 weeks after randomization or earlier at discontinuation of phototherapy	Measure of clinical treatment response, with PGA score of 0/1 (clear/almost clear). PGA score range from 0 (clear) to 5 (worst disease state).
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)	12 weeks after randomization or earlier at discontinuation of phototherapy	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

Name	Time	Method
Total Number of Phototherapy Treatments Received	12 weeks after randomization or earlier at discontinuation of phototherapy	patient or site reported phototherapy dosing
Cumulative Dose of Phototherapy Received	12 weeks after randomization or earlier at discontinuation of phototherapy	Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.
Concomitant Topical Psoriasis Treatment	week 12 and week 24 after randomization	Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments	week 12 and week 24 after randomization
Patient-reported Time Spent on Phototherapy Per Treatment	12 weeks after randomization or earlier at discontinuation of phototherapy	patient reported survey
Patient Reported Costs Associated With Travel for Phototherapy Treatments	12 weeks after randomization or earlier at discontinuation of phototherapy	patient reported survey for Office patients only
Patient Reported Time Associated With Travel for Phototherapy Treatments	12 weeks after randomization or earlier at discontinuation of phototherapy	patient reported survey for Office patients only
DLQI (0-1)	12 weeks after randomization or earlier at discontinuation of phototherapy	Dermatology Life Quality Index (DLQI) score of ≤1 which corresponds to no 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
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI	12 weeks after randomization or earlier at discontinuation of phototherapy	A difference of 4 was determined to be the MCID
Physician Global Assessment Times Body Surface Area (PGAxBSA)	12 weeks after randomization or earlier at discontinuation of phototherapy	The difference in PGAxBSA from baseline to week 12. Values range from -500 to 500, with negative values indicating improvement in disease.; BSA is a measure of 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. PGA is previously described. The product of the two measurements (PGA×BSA) has been investigated to assess psoriasis severity, with higher values indicating greater disease burden.; Reference: Chiesa Fuxench et al. Validity of the simple-measure for assessing psoriasis activity (S-MAPA) for objectively evaluating disease severity in patients with plaque psoriasis. J Am Acad Dermatol 2015;73:868-7.
PGA x BSA 75%	12 weeks after randomization or earlier at discontinuation of phototherapy	Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12
PGA x BSA 90%	12 weeks after randomization or earlier at discontinuation of phototherapy	Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12
Duration of Treatment Response During Observation Period	24 weeks after randomization	Defined as the length of time from week 12 to the earliest of DLQI \> 5 or time of initiation of a new systemic treatment or dose escalation of an existing systemic treatment, with patients who maintain DLQI \<=5 5 throughout the 12 week observation period with no new systemic treatments or dose escalation censored at week 24.
Patients Receiving at Least 80% of Treatments	12 weeks after randomization or earlier at discontinuation of phototherapy	80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.

Trial Locations

Locations (38)

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Total Skin & Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Johnson Dermatology; 🇺🇸 Fort Smith, Arkansas, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Howard University; 🇺🇸 Washington, District of Columbia, United States

Dawes Fretzin Clinical Research; 🇺🇸 Indianapolis, Indiana, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

MD Claiborne and Associates, LLC; 🇺🇸 New Orleans, Louisiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

MaineHealth/Maine Medical Center; 🇺🇸 Portland, Maine, United States

DermAssociates LLC; 🇺🇸 Silver Spring, Maryland, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Dermatology Specialist of Brighton; 🇺🇸 Brighton, Michigan, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Heymann, Manders, Green, and Sommer, LLC; 🇺🇸 Marlton, New Jersey, United States

Psoriasis Treatment Center of Central New Jersey; 🇺🇸 East Windsor, New Jersey, United States

HHC Kings County Hospital; 🇺🇸 Brooklyn, New York, United States

SUNY Downstate Health Sciences University; 🇺🇸 Brooklyn, New York, United States

Buffalo Medical Group; 🇺🇸 Buffalo, New York, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Infinity Dermatology NYC; 🇺🇸 Queens, New York, United States

Pennsyvlania Centre For Dermatology; 🇺🇸 Exton, Pennsylvania, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Dermatology Treatment and Research Center; 🇺🇸 Dallas, Texas, United States

West Houston Dermatology; 🇺🇸 Houston, Texas, United States

Menter Dermatology Research Institute; 🇺🇸 Dallas, Texas, United States

University of Vermont & State Agriculture College; 🇺🇸 Burlington, Vermont, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Frontier Derm Partners CRO, LLC; 🇺🇸 Mill Creek, Washington, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States