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Light Treatment Effectiveness (LITE) Study

NCT03726489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 783

Last updated 2024-09-19

Study results available
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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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Joel M. Gelfand, MD,MSCE · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2023-10-31
Completion
2023-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726489 on ClinicalTrials.gov