Light Treatment Effectiveness (LITE) Study

University of Pennsylvania

Status: Completed

Conditions: Psoriasis; Psoriatic Plaque

Treatments: Device: narrow band phototherapy clinic units; Device: Daavlin 7 series 3 panel narrow band phototherapy home units

Study type: Interventional

Funder types: Other

Identifiers

NCT03726489

831323

PCS-1608-35830 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 783 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing and able to provide informed consent (age 18+) or parental permission and assent (ages 12-17)

2. Age 12 or older

3. 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

4. Patient is deemed willing and able to comply with either in-office or in-home phototherapy:

   1. 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
   2. In home: Has space to accommodate home phototherapy unit and patient (or if 12-17, parent), willing and able to follow home phototherapy instructions

5. New or established patient in the practice

Exclusion criteria

1. 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

2. Patients judged unable to follow home phototherapy protocol due to failure to demonstrate understanding of the following:

   1. How to operate the phototherapy device
   2. How to follow the dosing protocol
   3. Requirement to wear protective eyewear and genital protection equipment

3. Patients with known history of lack of efficacy to phototherapy or treated with phototherapy 14 days prior to baseline visit

4. Psoriasis predominantly located on scalp, body folds, genitals, palms and/or soles or with a physician global assessment average of ≤ 1.0

5. Patients deemed unsafe to be treated with phototherapy:

   1. History of photosensitivity or autoimmune disease such as lupus or dermatomyositis which can be aggravated by ultraviolet radiation
   2. History of arsenic intake
   3. Unable to tolerate standing for required duration of treatment due to age or physical function
   4. History of melanoma or multiple non-melanoma skin cancers that in the opinion of the principal investigator contraindicates treatment with phototherapy

6. Clinical site deems the participant is ineligible for reason other than eligibility or screening criteria.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

783 participants in 2 patient groups

Office Based Phototherapy

Other group

Description:

Patients randomized to this arm will receive narrow band phototherapy in a clinical setting via narrow band phototherapy clinic units.

Treatment:

Device: narrow band phototherapy clinic units

Home Based Phototherapy

Active Comparator group

Description:

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.

Treatment:

Device: Daavlin 7 series 3 panel narrow band phototherapy home units