Raynaud DiseaseNCT04898036
Phototherapy For Treatment Of Raynaud's Phenomenon
A study testing Blue Light Therapy in people with Raynaud Disease and Raynaud Phenomenon, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Raynaud Disease, Raynaud Phenomenon, Raynaud Syndrome
- What is being tested?
- Blue Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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
- Being tested
- Blue Light Therapy, Sham Light Therapy
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Light TherapyDevice
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.
Sham Light TherapyDevice
To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.
| Study group | Role | What they receive |
|---|---|---|
| Sham First, then Experimental | Experimental | Participants in this group will receive the sham treatment first, then the experimental treatment. Receives: Device: Blue Light Therapy; Device: Sham Light Therapy |
| Experimental First, then Sham | Experimental | Participants in this group will receive the experimental treatment first, then the sham treatment. Receives: Device: Blue Light Therapy; Device: Sham Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) of Pain
Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
Measured: 4 hours
Change in Visual Analog Scale (VAS) of Numbness
Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
Measured: 4 hours
Secondary outcomes (1)
Skin Temperature
Skin temperature of at least one finger will be measured and logged using a thermometer at multiple points during study visit. Outcome is reported in units of degrees Celsius.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study startAug 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: no funding or staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jerry Molitor, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898036
- Sponsor's protocol ID
- RHEUM-2021-29567
- Status last verified
- Jan 2023
- First submitted
- 18 May 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy For Treatment Of Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT04898036
- Acronym / sponsor ID
- RHEUM-2021-29567
- Conditions
- Raynaud Disease, Raynaud Phenomenon, Raynaud Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding or staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham First, then Experimental | Experimental | Device: Blue Light Therapy, Device: Sham Light TherapyParticipants in this group will receive the sham treatment first, then the experimental treatment. |
| Experimental First, then Sham | Experimental | Device: Blue Light Therapy, Device: Sham Light TherapyParticipants in this group will receive the experimental treatment first, then the sham treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must have a current diagnosis by a physician of Raynaud's Phenomenon/Syndrome
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue Light TherapyThis 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 | Experimental First, then Sham, Sham First, then Experimental |
| Sham Light TherapyTo turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands. | Device | Experimental First, then Sham, Sham First, then Experimental |
Primary outcome
Change in Visual Analog Scale (VAS) of Pain
Time frame: 4 hours
Participants will be asked to rate their pain upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
Change in Visual Analog Scale (VAS) of Numbness
Time frame: 4 hours
Participants will be asked to rate their numbness upon cold room exposure between treatments using a 10 centimeter visual analog scale (VAS). Outcome is reported as the mean change in VAS per arm in units of millimeters.
1 secondary outcome
Skin Temperature
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Molitor, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Light Therapy in people with Raynaud Disease and Raynaud Phenomenon, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) of Pain (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.