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
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
783
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
Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
Physician Global Assessment (PGA) Score of Clear/Almost Clear
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).
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Impact of Dermatological Disease on Quality of Life (DLQI ≤5)
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 or earlier at discontinuation of phototherapy
Total Number of Phototherapy Treatments Received
patient or site reported phototherapy dosing
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Cumulative Dose of Phototherapy Received
Cumulative dose of photherapy is the sum of all individual doses from randomization to week 12 visit.
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Concomitant Topical Psoriasis Treatment
Patient reported topical psoriasis treatment - number of days per week the patient takes topical medication
Time frame: week 12 and week 24 after randomization
Changes in Initiation or Discontinuation of Oral or Biologic Psoriasis Treatments
Time frame: week 12 and week 24 after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
University of Southern California
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Dawes Fretzin Clinical Research
Indianapolis, Indiana, United States
MD Claiborne and Associates, LLC
New Orleans, Louisiana, United States
...and 28 more locations
Patient-reported Time Spent on Phototherapy Per Treatment
patient reported survey
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Costs Associated With Travel for Phototherapy Treatments
patient reported survey for Office patients only
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Patient Reported Time Associated With Travel for Phototherapy Treatments
patient reported survey for Office patients only
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
DLQI (0-1)
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
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI
A difference of 4 was determined to be the MCID
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Physician Global Assessment Times Body Surface Area (PGAxBSA)
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.
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 75%
Binary outcome of achieving 75% reduction in PGA x BSA from baseline to week 12
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
PGA x BSA 90%
Binary outcome of achieving 90% reduction in PGA x BSA from baseline to week 12
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy
Duration of Treatment Response During Observation Period
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.
Time frame: 24 weeks after randomization
Patients Receiving at Least 80% of Treatments
80% of assigned treatments is defined as 24 total treatments. Patients must have at least one treatment to be included.
Time frame: 12 weeks after randomization or earlier at discontinuation of phototherapy