CompletedNot Applicable

Light Treatment Effectiveness (LITE) Study

United States783 participantsStarted 2019-03-01

Plain-language 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

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

What they're measuring

Physician Global Assessment (PGA) Score of Clear/Almost Clear

Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapy

Impact of Dermatological Disease on Quality of Life (DLQI ≤5)

Timeframe: 12 weeks after randomization or earlier at discontinuation of phototherapy

Trial details

NCT IDNCT03726489

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-31

Results submitted2024-07-01

View on ClinicalTrials.gov More Psoriasis trials