NCT03726489

Light Treatment Effectiveness (LITE) Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 783 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Psoriasis
• Psoriatic Plaque

Interventions

Type	Name	Description
DEVICE	Daavlin 7 series 3 panel narrow band phototherapy home units	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
DEVICE	narrow band phototherapy clinic units	Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-10-31
• Completion: 2023-12-30
• First posted: 2018-10-31
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated device study