NCT04898036

Phototherapy For Treatment Of Raynaud's Phenomenon

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to test the efficacy of blue light phototherapy for the treatment of Raynaud's phenomenon (RP) in human participants. The specific aim is to see if phototherapy treatment applied to the hands will reduce the symptoms that RP participants experience. This will be measured through the use of a visual analog scale (VAS) of both pain and numbness. This study will also help to infer whether blue light phototherapy causes vasodilation through infrared thermal imaging of the hands and continuous measurement of skin temperature with a surface thermistor. Together, the visual analog scale (VAS) and infrared thermal imaging contribute to the objective of deducing whether blue light phototherapy can lead to reduced RP symptoms due to vasodilation of blood vessels.

Conditions

• Raynaud Disease
• Raynaud Phenomenon
• Raynaud Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-05-24
• Last updated: 2023-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study