Phototherapy For Treatment Of Raynaud's Phenomenon

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 50 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome.

Exclusion Criteria:

- Those with active ischemic digital ulcers or gangrene as the cold exposure can be a safety hazard for them.

- Inability of the subject to place their hands into the PTD portal because of physical size or discomfort.

- Inability of the subject to wear protective eyewear.

- Anyone, who in the judgement of any of the investigators, would be unable to safely complete the study procedures.

- Females who are pregnant.

- Adults unable to consent for any reason not explicitly stated herein.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04898036
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Minnesota
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jerry Molitor, MD, PhD
Principal Investigator Affiliation	University of Minnesota
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Raynaud Disease, Raynaud Phenomenon, Raynaud Syndrome

Additional Details

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.

Arms & Interventions

Arms

Experimental: Sham First, then Experimental

Participants in this group will receive the sham treatment first, then the experimental treatment.

Experimental: Experimental First, then Sham

Participants in this group will receive the experimental treatment first, then the sham treatment.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

James Kerber

[email protected]

612-624-5346

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