Light Treatment Effectiveness (LITE) Study

Psoriasis Clinical Trial

— LITE  

Official title:

A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726489
• Other study ID #: 831323
• Secondary ID: PCS-1608-35830
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 783
• Est. completion date: December 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriatic Plaque

Intervention

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
• narrow band phototherapy clinic units
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Johns Hopkins University	Baltimore	Maryland
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dermatology Specialist of Brighton	Brighton	Michigan
United States	Montefiore Medical Center	Bronx	New York
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	University of Vermont & State Agriculture College	Burlington	Vermont
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Dermatology Treatment and Research Center	Dallas	Texas
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Pennsyvlania Centre For Dermatology	Exton	Pennsylvania
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	West Houston Dermatology	Houston	Texas
United States	Dawes Fretzin Clinical Research	Indianapolis	Indiana
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Heymann, Manders, Green, and Sommer, LLC	Marlton	New Jersey
United States	Frontier Derm Partners CRO, LLC	Mill Creek	Washington
United States	MD Claiborne and Associates, LLC	New Orleans	Louisiana
United States	Temple University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	MaineHealth/Maine Medical Center	Portland	Maine
United States	Infinity Dermatology NYC	Queens	New York
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	DermAssociates LLC	Silver Spring	Maryland
United States	George Washington University	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Psoriasis Foundation, Patient-Centered Outcomes Research Institute, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Response	measured by Physician Global Assessment (PGA) score of clear/almost clear	12 weeks after randomization or earlier at discontinuation of phototherapy
Primary	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	12 weeks after randomization
Secondary	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	12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary	Concomitant topical psoriasis treatment	Patient reported topical psoriasis treatment	24 weeks after randomization
Secondary	Patient reported time associated with travel for phototherapy treatments	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary	Patient reported costs associated with travel for phototherapy treatments	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary	Patient reported time spent on phototherapy	patient reported survey	12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary	Phototherapy Dosing	patient or site reported phototherapy dosing	12 weeks after randomization or earlier at discontinuation of phototherapy
Secondary	Duration of treatment response during observation period	patient reported response to treatment	24 weeks after randomization