A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- University of Pennsylvania
- Enrollment
- 783
- Locations
- 38
- Primary Endpoint
- Physician Global Assessment (PGA) Score of Clear/Almost Clear
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Physician Global Assessment (PGA) Score of Clear/Almost Clear
Time Frame: 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)
Time Frame: 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 Outcomes
- Total Number of Phototherapy Treatments Received(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Cumulative Dose of Phototherapy Received(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Concomitant Topical Psoriasis Treatment(week 12 and week 24 after randomization)
- 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 Costs Associated With Travel for Phototherapy Treatments(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Patient Reported Time Associated With Travel for Phototherapy Treatments(12 weeks after randomization or earlier at discontinuation of phototherapy)
- DLQI (0-1)(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Achievement of a Minimal Clinically Important Difference (MCID) on the DLQI(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Physician Global Assessment Times Body Surface Area (PGAxBSA)(12 weeks after randomization or earlier at discontinuation of phototherapy)
- PGA x BSA 75%(12 weeks after randomization or earlier at discontinuation of phototherapy)
- PGA x BSA 90%(12 weeks after randomization or earlier at discontinuation of phototherapy)
- Duration of Treatment Response During Observation Period(24 weeks after randomization)
- Patients Receiving at Least 80% of Treatments(12 weeks after randomization or earlier at discontinuation of phototherapy)