Luminance RED for Canker Sores
Primary Purpose
Canker Sore
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminance RED Low Level Laser Therapy Device
Sponsored by
About this trial
This is an interventional treatment trial for Canker Sore
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- ProofPilot Virtual Online Trial (https://proofpilot.com)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm
Arm Description
Luminance Red Treatment Arm
Outcomes
Primary Outcome Measures
Change in Visual Analog Pain Scale
daily score of canker sore pain
Change in Eating, drinking, and brushing teeth questionnaire
score calculated on daily discomfort with eating, drinking and brushing teath
Secondary Outcome Measures
Device retention
Percentage of participants who decide to keep device
Full Information
NCT ID
NCT04914533
First Posted
May 31, 2021
Last Updated
June 3, 2021
Sponsor
ProofPilot
Collaborators
Luminance RED
1. Study Identification
Unique Protocol Identification Number
NCT04914533
Brief Title
Luminance RED for Canker Sores
Official Title
Exploratory Real-world Study Examining the Effect of the Luminance RED Device on Recurrent Aphthous Ulcer Stomatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2021 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Luminance RED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Canker Sore
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Luminance Red Treatment Arm
Intervention Type
Device
Intervention Name(s)
Luminance RED Low Level Laser Therapy Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analog Pain Scale
Description
daily score of canker sore pain
Time Frame
Baseline to day 18
Title
Change in Eating, drinking, and brushing teeth questionnaire
Description
score calculated on daily discomfort with eating, drinking and brushing teath
Time Frame
Baseline to day 18
Secondary Outcome Measure Information:
Title
Device retention
Description
Percentage of participants who decide to keep device
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew M Amsden
Phone
(888) 870-4189
Email
crew@proofpilot.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew M Amsden
Organizational Affiliation
ProofPilot
Official's Role
Principal Investigator
Facility Information:
Facility Name
ProofPilot Virtual Online Trial (https://proofpilot.com)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Luminance RED for Canker Sores
We'll reach out to this number within 24 hrs