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.
Condition or Disease
Psoriasis
Psoriatic Plaque
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 Design
| Study Type: | Interventional (Clinical Trial) |
| Estimated Enrollment: | 1050 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Pragmatic, randomized, active comparator effectiveness study |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis |
| Actual Study Start Date: | March 1, 2019 |
| Estimated Primary Completion Date: | July 31, 2022 |
| Estimated Study Completion Date: | October 31, 2022 |
Outcome Measures
Primary Outcome Measures
- Treatment Response [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
measured by Physician Global Assessment (PGA) score of clear/almost clear
- Impact of dermatological disease on quality of life [ Time Frame: 12 weeks after randomization ]
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 [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
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 [ Time Frame: 24 weeks after randomization ]
Patient reported topical psoriasis treatment
- Patient reported time associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
patient reported survey
- Patient reported costs associated with travel for phototherapy treatments [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
patient reported survey
- Patient reported time spent on phototherapy [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
patient reported survey
- Phototherapy Dosing [ Time Frame: 12 weeks after randomization or earlier at discontinuation of phototherapy ]
patient or site reported phototherapy dosing
- Duration of treatment response during observation period [ Time Frame: 24 weeks after randomization ]
patient reported response to treatment
Eligibility Criteria
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 instruction.
- 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.