Light Treatment Effectiveness (LITE) Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psoriasis, Psoriatic Plaque

Intervention / Treatment
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* Device: Daavlin 7 series 3 panel narrow band phototherapy home units
* Device: narrow band phototherapy clinic units


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, randomized, active comparator effectiveness study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Office Based Phototherapy<br>Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units. | Device: narrow band phototherapy clinic units<br>* Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure<br>|
| Active Comparator: Home Based Phototherapy<br>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. | Device: Daavlin 7 series 3 panel narrow band phototherapy home units<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Response | measured by Physician Global Assessment (PGA) score of clear/almost clear | 12 weeks after randomization or earlier at discontinuation of phototherapy | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Concomitant topical psoriasis treatment | Patient reported topical psoriasis treatment | 24 weeks after randomization | 
| Patient reported time associated with travel for phototherapy treatments | patient reported survey | 12 weeks after randomization or earlier at discontinuation of phototherapy | 
| Patient reported costs associated with travel for phototherapy treatments | patient reported survey | 12 weeks after randomization or earlier at discontinuation of phototherapy | 
| Patient reported time spent on phototherapy | patient reported survey | 12 weeks after randomization or earlier at discontinuation of phototherapy | 
| Phototherapy Dosing | patient or site reported phototherapy dosing | 12 weeks after randomization or earlier at discontinuation of phototherapy | 
| Duration of treatment response during observation period | patient reported response to treatment | 24 weeks after randomization |