A Pragmatic Trial of Home Versus Office Based Narrow Band Ultraviolet B Phototherapy for the Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 783
- 试验地点
- 76
- 主要终点
- Physician Global Assessment (PGA) Score of Clear/Almost Clear
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Office Based Phototherapy
Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.
干预措施: narrow band phototherapy clinic units (Device)
Home Based Phototherapy
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.
干预措施: Daavlin 7 series 3 panel narrow band phototherapy home units (Device)
结局指标
主要结局
Physician Global Assessment (PGA) Score of Clear/Almost Clear
时间窗: 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)
时间窗: 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
次要结局
- 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)