Canker SoreNCT04914533
Luminance RED for Canker Sores
A study testing Luminance RED Low Level Laser Therapy Device in people with Canker Sore, run by ProofPilot at 1 site in United States.
Trial summary
Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Canker Sore
- What is being tested?
- Luminance RED Low Level Laser Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2021to 28 Sep 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- 18 years and older.
- Self report canker sore outbreaks once every 30 days or more frequent
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- No previous experience of LLLT.
- United States resident.
- Willingness and ability to submit a $49 deposit using a credit card for the device.
Who cannot join
- Patients with a known systemic disease that predisposes them to RAS (e.g., Behçet disease) or undergoing systemic treatment for RAS.
- The presence of a serious medical condition.
- Currently known to be pregnant or breastfeeding
- Patients treated with topical or systemic medication for RAS, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot Virtual Online Trial (https://proofpilot.com)
New York, New York, 10003
About this study
Official title: Exploratory Real-world Study Examining the Effect of the Luminance RED Device on Recurrent Aphthous Ulcer Stomatitis
Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Recurrent aphthous ulcer stomatitis (RAS) is characterized by recurrent bouts of solitary or multiple shallow painful ulcers, at intervals of a few months to a few days in patients who are otherwise well.
Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors, which trigger chemical changes.
Read more
The main medical usage of LLLT is for pain and inflammation reduction, promoting the regeneration of different tissues and preventing damage to tissues. With the use of the appropriate power (from 5 to 200mW) and wavelength (600-900nm), the therapy brings anti-inflammatory and analgesic results aiding in wound healing. The mechanism of action of LLLT may be very beneficial in the treatment of oral erosions and ulcers, however, very few studies have been performed on the treatment of RAS with LLLT. There are few reports on accelerated healing in erosive mucocutaneous disorders and they are often presented as a case series rather than large randomized clinical trials. The effects on skin wound healing and periodontal inflammation management with laser biostimulation suggest that this treatment modality may also be useful for oral erosive conditions.
This clinical trial aims to evaluate the effect of the Luminance RED device on the management of RAS.
- Conditions
- Canker Sore
- Being tested
- Luminance RED Low Level Laser Therapy Device
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminance RED Low Level Laser Therapy DeviceDevice
Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The Luminance RED Device is specifically designed to make it easy to issue LLLT to canker sores.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Luminance Red Treatment Arm Receives: Device: Luminance RED Low Level Laser Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Pain Scale
daily score of canker sore pain
Measured: Baseline to day 18
Change in Eating, drinking, and brushing teeth questionnaire
score calculated on daily discomfort with eating, drinking and brushing teath
Measured: Baseline to day 18
Secondary outcomes (1)
Device retention
Percentage of participants who decide to keep device
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start21 Jun 2021 (estimated)
- Primary completion1 Sep 2021
- Study completion28 Sep 2021
Why it stopped: did not launch
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Canker SoreStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Luminance RED
- Responsible party
- Sponsor
- Investigators
- Matthew M Amsden, Principal investigator, ProofPilot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914533
- Sponsor's protocol ID
- 2795
- Status last verified
- Dec 2024
- First submitted
- 31 May 2021
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Real-world Study Examining the Effect of the Luminance RED Device on Recurrent Aphthous Ulcer Stomatitis
- ClinicalTrials.gov ID
- NCT04914533
- Acronym / sponsor ID
- 2795
- Conditions
- Canker Sore
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not launch
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Luminance RED
- Study start
- 21 Jun 2021 (estimated)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 4 Jun 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.
Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Recurrent aphthous ulcer stomatitis (RAS) is characterized by recurrent bouts of solitary or multiple shallow painful ulcers, at intervals of a few months to a few days in patients who are otherwise well.
Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors, which trigger chemical changes.
The main medical usage of LLLT is for pain and inflammation reduction, promoting the regeneration of different tissues and preventing damage to tissues. With the use of the appropriate power (from 5 to 200mW) and wavelength (600-900nm), the therapy brings anti-inflammatory and analgesic results aiding in wound healing. The mechanism of action of LLLT may be very beneficial in the treatment of oral erosions and ulcers, however, very few studies have been performed on the treatment of RAS with LLLT. There are few reports on accelerated healing in erosive mucocutaneous disorders and they are often presented as a case series rather than large randomized clinical trials. The effects on skin wound healing and periodontal inflammation management with laser biostimulation suggest that this treatment modality may also be useful for oral erosive conditions.
This clinical trial aims to evaluate the effect of the Luminance RED device on the management of RAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Luminance RED Low Level Laser Therapy DeviceLuminance Red Treatment Arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- 18 years and older.
- Self report canker sore outbreaks once every 30 days or more frequent
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- No previous experience of LLLT.
Key exclusion criteria (4 listed)
- Patients with a known systemic disease that predisposes them to RAS (e.g., Behçet disease) or undergoing systemic treatment for RAS.
- The presence of a serious medical condition.
- Currently known to be pregnant or breastfeeding
- Patients treated with topical or systemic medication for RAS, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
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 |
|---|---|---|
| Luminance RED Low Level Laser Therapy DeviceLow Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The Luminance RED Device is specifically designed to make it easy to issue LLLT to canker sores. | Device | Intervention Arm |
Primary outcome
Change in Visual Analog Pain Scale
Time frame: Baseline to day 18
daily score of canker sore pain
Change in Eating, drinking, and brushing teeth questionnaire
Time frame: Baseline to day 18
score calculated on daily discomfort with eating, drinking and brushing teath
1 secondary outcome
Device retention
Time frame: Day 21
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 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
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Oxygenated Gel Therapy in the Management of Oral Aphthous Ulcers
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Evaluation of Topical Rebamipide Versus Topical Betamethasone for Treatment of Oral Aphthous Ulcers
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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.
Matthew M Amsden principal investigator
ProofPilot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminance RED Low Level Laser Therapy Device in people with Canker Sore, run by ProofPilot 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 7 inclusion and 4 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 17 Sep 2026. 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 Pain Scale (time frame: Baseline to day 18). 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 17 Sep 2026.