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Phototherapy For Treatment Of Raynaud's Phenomenon

NCT04898036 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-06

No results posted yet for this study

Summary

To determine if blue light therapy can improve the symptoms of Raynaud's phenomenon, and provide parameters for ultimately designing commercial treatment devices, an investigational stationary phototherapy unit was designed and built.

Conditions

  • Raynaud Disease
  • Raynaud Phenomenon
  • Raynaud Syndrome

Interventions

DEVICE

Blue Light Therapy

This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.

DEVICE

Sham Light Therapy

To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.

Sponsors & Collaborators

Principal Investigators

  • Jerry Molitor, MD, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04898036 on ClinicalTrials.gov