Fibrosis, Hypertrophic Scar, Keloid, Scar, Skin Scarring, Skin Wound
Conditions
Keywords
Light emitting diode, Light emitting diode-red light, Visible red light, Skin fibrosis, Wound healing, Scarring
Brief summary
Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.
Detailed description
Skin fibrosis is a significant global health problem that has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis. In vitro data show that LED-RL can modulate key cellular and molecular processes involved in skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars.
Interventions
DEVICELED-RL phototherapy
The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
DEVICEMock irradiation
The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
Sponsors
State University of New York - Downstate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a single-blind study. Participants and clinicians involved in subjective efficacy assessments will be blind to the study intervention (LED-RL phototherapy versus mock therapy). The principal investigator, along with the research coordinator who administers the LED-RL phototherapy, will be aware of each participant's treatment assignment.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent for all study procedures * Stated willingness to comply with all study procedures and availability for the duration of the study * Suitable candidate for elective mini-facelift surgery * Pass a screening photosensitivity test
Exclusion criteria
* Current use of any photosensitizing medications * Light-sensitive conditions * Diabetes mellitus * Systemic lupus erythematosus * Current tobacco use * History of bleeding or coagulation disorder * Lax skin associated with genetic disorders * Open wounds on the face or neck * Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the periauricular skin * History of surgery or procedure involving or affecting the periauricular skin within the past 6 months (e.g., prior facelift, fillers, laser therapy) * Tattoos that cover the proposed treatment sites on the periauricular skin * Any other medical condition(s) that could be compromised by exposure to the proposed treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline | 1 month, 3 months, 6 months | The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m). |
| Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Collagen Concentration | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis. |
| Dermal Water Concentration | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%. |
| 3D Imaging Analysis: Pigmentation of Scar Tissue | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site. |
| 3D Imaging Analysis: Vascularity of Scar Tissue | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site. |
| Observer Scar Assessment Scale | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | The scale consists of six items rated from 1 to 10, where 1 is normal skin and 10 is the worst imaginable scar. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60). |
| Histological Analysis: Collagen Content of Scar Tissue (Optional) | Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment). | The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers. |
| Number of Participants Experiencing Adverse Events in Each Treatment Group | From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up). | Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects. |
| Patient Scar Assessment Scale | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | The scale consists of six items rated from 1 to 10, where 1 is normal skin and 10 is the worst imaginable scar. The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60). |
| 3D Imaging Analysis: Volume of Elevation of Scar Tissue | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site. |
| Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars | Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months). | The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates normal skin and 10 corresponds to the worst possible scar, for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity. |
Countries
United States
Participant flow
Pre-assignment details
30 participants were included in the study. This was a split-face study in which each patient received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Group 1 30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 1 participants received Low dose LED-RL (160 J/cm2) for 30 minutes on one incision site and mock phototherapy for 30 minutes on the other incision site. | 10 |
| All Participants Group 2 30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 2 participants received medium dose LED-RL (320 J/cm2) for 60 minutes on one incision site and mock phototherapy for 60 minutes on the other incision site. | 10 |
| All Participants Group 3 30 subjects were randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week after surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks.
Group 3 participants received high dose LED-RL (480 J/cm2) for 90 minutes on one incision site and mock phototherapy for 90 minutes on the other incision site. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants Group 1 | All Participants Group 2 | All Participants Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 8.2 | 52.4 years STANDARD_DEVIATION 7.2 | 56.3 years STANDARD_DEVIATION 7.4 | 54.1 years STANDARD_DEVIATION 7.5 |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Two or more races | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White hispanic | 2 participants | 3 participants | 1 participants | 6 participants |
| Race/Ethnicity, Customized White non-hispanic | 5 participants | 6 participants | 8 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 1 / 10 | 0 / 10 | 2 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline
The ElastiMeter, a non-invasive indentation instrument, will be used to evaluate skin elasticity (i.e., skin stiffness) of the LED-RL-treated scar versus the untreated scar. Skin elasticity is measured in Newtons/meters (N/m).
Time frame: 1 month, 3 months, 6 months
Population: Collected data were not considered valid due to an equipment malfunction.
Primary
Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline
The SkinFibroMeter, a non-invasive indentation instrument, will be used to evaluate the induration of the skin and subcutaneous tissue (i.e., hardness) of the LED-RL-treated scar versus the untreated scar. Skin induration is measured in Newtons (N).
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| LED-RL Phototherapy | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .08 Newton |
| LED-RL Phototherapy | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .05 Newton |
| LED-RL Phototherapy | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .03 Newton |
| LED-RL Phototherapy | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .03 Newton |
| Mock Irradiation | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .04 Newton |
| Mock Irradiation | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .04 Newton |
| Mock Irradiation | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .05 Newton |
| Mock Irradiation | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .03 Newton |
| LED-RL Phototherapy Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .02 Newton |
| LED-RL Phototherapy Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .04 Newton |
| LED-RL Phototherapy Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .06 Newton |
| LED-RL Phototherapy Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .09 Newton |
| Mock Irradiation Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .06 Newton |
| Mock Irradiation Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .03 Newton |
| Mock Irradiation Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .05 Newton |
| Mock Irradiation Group 2 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .04 Newton |
| LED-RL Phototherapy Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .05 Newton |
| LED-RL Phototherapy Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .03 Newton |
| LED-RL Phototherapy Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .05 Newton |
| LED-RL Phototherapy Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .06 Newton |
| Mock Irradiation Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 1 month | .04 Newton |
| Mock Irradiation Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 3 months | .06 Newton |
| Mock Irradiation Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | 6 months | .02 Newton |
| Mock Irradiation Group 3 | Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline | Baseline | .07 Newton |
Secondary
3D Imaging Analysis: Pigmentation of Scar Tissue
A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of pigmentation at each incision site.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: Data were not collected for this outcome measure.
Secondary
3D Imaging Analysis: Vascularity of Scar Tissue
A 3D digital imaging system will be used to construct 3D images of the scars for colorimetric analyses, including quantitative measurements of vascularity at each incision site.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: Data were not collected for this outcome measure.
Secondary
3D Imaging Analysis: Volume of Elevation of Scar Tissue
A 3D digital imaging system will be used to construct 3D images of the scars for skin profilometry analyses, including quantitative measurements of tissue volume at each incision site.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: Data were not collected for this outcome measure.
Secondary
Dermal Collagen Concentration
A non-invasive, handheld diffuse reflectance probe will be used to measure collagen concentration in the dermis at each incision site. The scale ranges from 10 to 99 and the collagen measurement corresponds to the half of the optical scattering coefficient of the dermis.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| LED-RL Phototherapy | Dermal Collagen Concentration | Baseline | 48.7 arbitrary units |
| LED-RL Phototherapy | Dermal Collagen Concentration | 1 month | 60.3 arbitrary units |
| LED-RL Phototherapy | Dermal Collagen Concentration | 3 months | 57.5 arbitrary units |
| LED-RL Phototherapy | Dermal Collagen Concentration | 6 months | 57.0 arbitrary units |
| Mock Irradiation | Dermal Collagen Concentration | 3 months | 57.4 arbitrary units |
| Mock Irradiation | Dermal Collagen Concentration | 1 month | 47.0 arbitrary units |
| Mock Irradiation | Dermal Collagen Concentration | Baseline | 52.0 arbitrary units |
| Mock Irradiation | Dermal Collagen Concentration | 6 months | 56.5 arbitrary units |
| LED-RL Phototherapy Group 2 | Dermal Collagen Concentration | 6 months | 60.0 arbitrary units |
| LED-RL Phototherapy Group 2 | Dermal Collagen Concentration | 3 months | 58.3 arbitrary units |
| LED-RL Phototherapy Group 2 | Dermal Collagen Concentration | 1 month | 50.7 arbitrary units |
| LED-RL Phototherapy Group 2 | Dermal Collagen Concentration | Baseline | 51.0 arbitrary units |
| Mock Irradiation Group 2 | Dermal Collagen Concentration | Baseline | 50.5 arbitrary units |
| Mock Irradiation Group 2 | Dermal Collagen Concentration | 6 months | 61.0 arbitrary units |
| Mock Irradiation Group 2 | Dermal Collagen Concentration | 1 month | 55.2 arbitrary units |
| Mock Irradiation Group 2 | Dermal Collagen Concentration | 3 months | 57.3 arbitrary units |
| LED-RL Phototherapy Group 3 | Dermal Collagen Concentration | 3 months | 58.7 arbitrary units |
| LED-RL Phototherapy Group 3 | Dermal Collagen Concentration | 6 months | 56.7 arbitrary units |
| LED-RL Phototherapy Group 3 | Dermal Collagen Concentration | 1 month | 52.7 arbitrary units |
| LED-RL Phototherapy Group 3 | Dermal Collagen Concentration | Baseline | 47.7 arbitrary units |
| Mock Irradiation Group 3 | Dermal Collagen Concentration | 1 month | 57.0 arbitrary units |
| Mock Irradiation Group 3 | Dermal Collagen Concentration | 3 months | 58.7 arbitrary units |
| Mock Irradiation Group 3 | Dermal Collagen Concentration | 6 months | 59.3 arbitrary units |
| Mock Irradiation Group 3 | Dermal Collagen Concentration | Baseline | 52.5 arbitrary units |
Secondary
Dermal Water Concentration
A non-invasive, handheld diffuse reflectance probe will be used to measure water concentration in the dermis at each incision site. Infrared light is emitted at different wavelengths to retrieve the scattering and the absorption coefficients of the dermis. The more water, the less reflectance. Concentration ranges from 40% to 85%.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| LED-RL Phototherapy | Dermal Water Concentration | Baseline | 63.0 percentage |
| LED-RL Phototherapy | Dermal Water Concentration | 1 month | 64.0 percentage |
| LED-RL Phototherapy | Dermal Water Concentration | 3 months | 63.0 percentage |
| LED-RL Phototherapy | Dermal Water Concentration | 6 months | 62.5 percentage |
| Mock Irradiation | Dermal Water Concentration | 3 months | 61.4 percentage |
| Mock Irradiation | Dermal Water Concentration | 1 month | 62.3 percentage |
| Mock Irradiation | Dermal Water Concentration | Baseline | 65.3 percentage |
| Mock Irradiation | Dermal Water Concentration | 6 months | 61.2 percentage |
| LED-RL Phototherapy Group 2 | Dermal Water Concentration | 6 months | 63.7 percentage |
| LED-RL Phototherapy Group 2 | Dermal Water Concentration | 3 months | 63.0 percentage |
| LED-RL Phototherapy Group 2 | Dermal Water Concentration | 1 month | 60.2 percentage |
| LED-RL Phototherapy Group 2 | Dermal Water Concentration | Baseline | 60.7 percentage |
| Mock Irradiation Group 2 | Dermal Water Concentration | Baseline | 62.7 percentage |
| Mock Irradiation Group 2 | Dermal Water Concentration | 6 months | 63.0 percentage |
| Mock Irradiation Group 2 | Dermal Water Concentration | 1 month | 62.3 percentage |
| Mock Irradiation Group 2 | Dermal Water Concentration | 3 months | 60.7 percentage |
| LED-RL Phototherapy Group 3 | Dermal Water Concentration | 3 months | 61.7 percentage |
| LED-RL Phototherapy Group 3 | Dermal Water Concentration | 6 months | 62.0 percentage |
| LED-RL Phototherapy Group 3 | Dermal Water Concentration | 1 month | 60.6 percentage |
| LED-RL Phototherapy Group 3 | Dermal Water Concentration | Baseline | 63.2 percentage |
| Mock Irradiation Group 3 | Dermal Water Concentration | 1 month | 64.0 percentage |
| Mock Irradiation Group 3 | Dermal Water Concentration | 3 months | 62.0 percentage |
| Mock Irradiation Group 3 | Dermal Water Concentration | 6 months | 64.0 percentage |
| Mock Irradiation Group 3 | Dermal Water Concentration | Baseline | 66.2 percentage |
Secondary
Histological Analysis: Collagen Content of Scar Tissue (Optional)
The histological changes that occur in vivo in response to LED-RL phototherapy will be evaluated by examination of pre- and post-treated skin tissue. Skin specimens will be obtained via optional 2 mm punch biopsy and stained for collagen fibers.
Time frame: Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).
Population: Biopsy was optional. This outcome measure was not performed for any subjects.
Secondary
Number of Participants Experiencing Adverse Events in Each Treatment Group
Subjects will be provided with a daily diary to record any adverse events experienced during the three-week intervention period. Treatment sessions will be monitored closely for the occurrence of any safety issues or adverse events, as reported by the subject or observed by the clinical research team. At each follow up visit, patients will be asked about adverse effects.
Time frame: From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).
Population: This was a split-face study including 30 participants. Each participant received LED-RL phototherapy (i.e. low, medium, or high dose) on one preauricular incision site and mock phototherapy on the other preauricular incision site.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LED-RL Phototherapy | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 0 Participants |
| LED-RL Phototherapy | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 0 Participants |
| LED-RL Phototherapy | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 10 Participants |
| Mock Irradiation | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 0 Participants |
| Mock Irradiation | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 0 Participants |
| Mock Irradiation | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 10 Participants |
| LED-RL Phototherapy Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 0 Participants |
| LED-RL Phototherapy Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 1 Participants |
| LED-RL Phototherapy Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 9 Participants |
| Mock Irradiation Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 0 Participants |
| Mock Irradiation Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 0 Participants |
| Mock Irradiation Group 2 | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 10 Participants |
| LED-RL Phototherapy Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 1 Participants |
| LED-RL Phototherapy Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 1 Participants |
| LED-RL Phototherapy Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 8 Participants |
| Mock Irradiation Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized bulla | 0 Participants |
| Mock Irradiation Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | no adverse events | 10 Participants |
| Mock Irradiation Group 3 | Number of Participants Experiencing Adverse Events in Each Treatment Group | localized facial swelling | 0 Participants |
Secondary
Observer Scar Assessment Scale
The scale consists of six items rated from 1 to 10, where 1 is normal skin and 10 is the worst imaginable scar. The observer (i.e., investigator) evaluates scar vascularity, pigmentation, thickness, relief, pliability, and surface area. The scores of each of the six items are summed for a total score (range 6 to 60).
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| LED-RL Phototherapy | Observer Scar Assessment Scale | 1 month | 17.0 score on a scale |
| LED-RL Phototherapy | Observer Scar Assessment Scale | 6 months | 9.0 score on a scale |
| LED-RL Phototherapy | Observer Scar Assessment Scale | Baseline | 16.5 score on a scale |
| LED-RL Phototherapy | Observer Scar Assessment Scale | 3 months | 12.5 score on a scale |
| Mock Irradiation | Observer Scar Assessment Scale | Baseline | 16.5 score on a scale |
| Mock Irradiation | Observer Scar Assessment Scale | 1 month | 17.0 score on a scale |
| Mock Irradiation | Observer Scar Assessment Scale | 3 months | 15.0 score on a scale |
| Mock Irradiation | Observer Scar Assessment Scale | 6 months | 12.5 score on a scale |
| LED-RL Phototherapy Group 2 | Observer Scar Assessment Scale | 1 month | 13.0 score on a scale |
| LED-RL Phototherapy Group 2 | Observer Scar Assessment Scale | Baseline | 19.0 score on a scale |
| LED-RL Phototherapy Group 2 | Observer Scar Assessment Scale | 3 months | 12.0 score on a scale |
| LED-RL Phototherapy Group 2 | Observer Scar Assessment Scale | 6 months | 8.0 score on a scale |
| Mock Irradiation Group 2 | Observer Scar Assessment Scale | 6 months | 14.0 score on a scale |
| Mock Irradiation Group 2 | Observer Scar Assessment Scale | 1 month | 17.5 score on a scale |
| Mock Irradiation Group 2 | Observer Scar Assessment Scale | Baseline | 14.0 score on a scale |
| Mock Irradiation Group 2 | Observer Scar Assessment Scale | 3 months | 14.0 score on a scale |
| LED-RL Phototherapy Group 3 | Observer Scar Assessment Scale | 3 months | 15.0 score on a scale |
| LED-RL Phototherapy Group 3 | Observer Scar Assessment Scale | 6 months | 13.0 score on a scale |
| LED-RL Phototherapy Group 3 | Observer Scar Assessment Scale | Baseline | 18.0 score on a scale |
| LED-RL Phototherapy Group 3 | Observer Scar Assessment Scale | 1 month | 19.0 score on a scale |
| Mock Irradiation Group 3 | Observer Scar Assessment Scale | 1 month | 13.0 score on a scale |
| Mock Irradiation Group 3 | Observer Scar Assessment Scale | 3 months | 13.0 score on a scale |
| Mock Irradiation Group 3 | Observer Scar Assessment Scale | Baseline | 16.5 score on a scale |
| Mock Irradiation Group 3 | Observer Scar Assessment Scale | 6 months | 12.0 score on a scale |
Secondary
Patient Scar Assessment Scale
The scale consists of six items rated from 1 to 10, where 1 is normal skin and 10 is the worst imaginable scar. The patient assesses pain, itching, color, stiffness, thickness, and irregularity. The scores of each of the six items are summed for a total score (range 6 to 60).
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: In this split-face study, 10 subjects were randomly assigned to each LED-RL group (low, medium, or high dose). While 30 subjects participated in the study, there were 60 total preauricular incision sites (in each participant, one site treated with LED-RL and the other with mock phototherapy). Due to subjects missing assessment visits (i.e. personal reasons, withdrawals, etc), there may be less than 10 subjects per group analyzed at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| LED-RL Phototherapy | Patient Scar Assessment Scale | Baseline | 36.0 score on a scale |
| LED-RL Phototherapy | Patient Scar Assessment Scale | 1 month | 25.0 score on a scale |
| LED-RL Phototherapy | Patient Scar Assessment Scale | 3 months | 12.5 score on a scale |
| LED-RL Phototherapy | Patient Scar Assessment Scale | 6 months | 12.0 score on a scale |
| Mock Irradiation | Patient Scar Assessment Scale | 3 months | 15.0 score on a scale |
| Mock Irradiation | Patient Scar Assessment Scale | 1 month | 25.0 score on a scale |
| Mock Irradiation | Patient Scar Assessment Scale | Baseline | 37.0 score on a scale |
| Mock Irradiation | Patient Scar Assessment Scale | 6 months | 10.5 score on a scale |
| LED-RL Phototherapy Group 2 | Patient Scar Assessment Scale | 6 months | 23.0 score on a scale |
| LED-RL Phototherapy Group 2 | Patient Scar Assessment Scale | 3 months | 18.0 score on a scale |
| LED-RL Phototherapy Group 2 | Patient Scar Assessment Scale | 1 month | 24.0 score on a scale |
| LED-RL Phototherapy Group 2 | Patient Scar Assessment Scale | Baseline | 32.0 score on a scale |
| Mock Irradiation Group 2 | Patient Scar Assessment Scale | Baseline | 30.5 score on a scale |
| Mock Irradiation Group 2 | Patient Scar Assessment Scale | 6 months | 18.0 score on a scale |
| Mock Irradiation Group 2 | Patient Scar Assessment Scale | 1 month | 23.5 score on a scale |
| Mock Irradiation Group 2 | Patient Scar Assessment Scale | 3 months | 21.0 score on a scale |
| LED-RL Phototherapy Group 3 | Patient Scar Assessment Scale | 3 months | 17.5 score on a scale |
| LED-RL Phototherapy Group 3 | Patient Scar Assessment Scale | 6 months | 13.0 score on a scale |
| LED-RL Phototherapy Group 3 | Patient Scar Assessment Scale | 1 month | 17.0 score on a scale |
| LED-RL Phototherapy Group 3 | Patient Scar Assessment Scale | Baseline | 26.5 score on a scale |
| Mock Irradiation Group 3 | Patient Scar Assessment Scale | 1 month | 26.0 score on a scale |
| Mock Irradiation Group 3 | Patient Scar Assessment Scale | 3 months | 20.0 score on a scale |
| Mock Irradiation Group 3 | Patient Scar Assessment Scale | 6 months | 17.0 score on a scale |
| Mock Irradiation Group 3 | Patient Scar Assessment Scale | Baseline | 28.5 score on a scale |
Secondary
Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars
The scar images will be rated by two independent, blinded dermatologists using a VAS. The VAS is presented as a 10 cm horizontal line, where the extreme ends of 0 indicates normal skin and 10 corresponds to the worst possible scar, for each of the following scar attributes: pigmentation, vascularity, observer comfort, contour, and overall severity.
Time frame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Population: Data were not collected for this outcome measure.