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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LED-RL phototherapy | Experimental | Thirty subjects will be 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. |
|
| Mock irradiation | Sham Comparator | Thirty subjects will be 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LED-RL phototherapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 month, 3 months, 6 months |
| 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31307501 | Derived | Nguyen JK, Weedon J, Jakus J, Heilman E, Isseroff RR, Siegel DM, Jagdeo JR. A dose-ranging, parallel group, split-face, single-blind phase II study of light emitting diode-red light (LED-RL) for skin scarring prevention: study protocol for a randomized controlled trial. Trials. 2019 Jul 15;20(1):432. doi: 10.1186/s13063-019-3546-6. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | LED-RL Phototherapy 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. LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes |
| FG001 | Mock Irradiation Group 1 | Thirty subjects will be 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. Mock irradiation group 1: Received mock phototherapy for 30 minutes. |
| FG002 | LED-RL Phototherapy 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. LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes |
| FG003 | Mock Irradiation Group 2 | Thirty subjects will be 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. Mock irradiation group 2: Received mock phototherapy for 60 minutes. |
| FG004 | LED-RL Phototherapy 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. LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes |
| FG005 | Mock Irradiation Group 3 | Thirty subjects will be 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. Mock irradiation group 3: Received mock phototherapy for 90 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 participants were enrolled and included in the split-face study (i.e., began the study protocol).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Collected data were not considered valid due to an equipment malfunction. | Posted | 1 month, 3 months, 6 months |
|
LED-RL and mock phototherapy treatment sessions were monitored for the occurrence of safety concerns and AEs, as reported by the patient or observed by the research team. Patients recorded AEs during the three-week LED-RL and mock phototherapy treatment period in a home diary. At each visit, participants were asked about AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LED-RL Phototherapy 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. LED-RL phototherapy group 1: Received Low dose LED-RL (160 J/cm2) for 30 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Localized Bulla | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jared Jagdeo MD, MS | SUNY Downstate Health Sciences University | 347-466-9263 | jared.jagdeo@downstate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Jul 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D002921 | Cicatrix |
| D017439 | Cicatrix, Hypertrophic |
| D007627 | Keloid |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
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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.
|
| Mock irradiation | Device | 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. |
|
| 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. | 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). |
| 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. | 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). |
| 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%. | 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). |
| 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. | 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). |
| 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. | 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). |
| 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. | 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). |
| 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. | 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). |
| 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. | 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). |
| 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). | 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). |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | Mock Irradiation | Thirty subjects will be 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. Mock 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. |
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | Newton | 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). | Incision Sites | Incision Sites |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | score on a 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). | Incision Sites | Incision Sites |
|
|
|
| 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. | Data were not collected for this outcome measure. | Posted | 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). |
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | arbitrary units | 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). | Incision Sites | Incision Sites |
|
|
|
| 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%. | 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. | Posted | Median | Inter-Quartile Range | percentage | 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). | Incision Sites | Incision Sites |
|
|
|
| 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. | Data were not collected for this outcome measure. | Posted | 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). |
|
|
| 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. | Data were not collected for this outcome measure. | Posted | 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). |
|
|
| 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. | Data were not collected for this outcome measure. | Posted | 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). |
|
|
| 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. | Biopsy was optional. This outcome measure was not performed for any subjects. | Posted | 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). |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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). |
|
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | score on a 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). | Incision Sites | Incision Sites |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Mock Irradiation Group 1 | 30 subjects will be 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. Mock irradiation group 1: Received mock phototherapy for 30 minutes. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | LED-RL Phototherapy 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. LED-RL phototherapy group 2: Received medium dose LED-RL (320 J/cm2) for 60 minutes. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG003 | Mock Irradiation Group 2 | 30 subjects will be 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. Mock irradiation group 2: Received mock phototherapy for 60 minutes. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG004 | LED-RL Phototherapy 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. LED-RL phototherapy group 3: Received high dose LED-RL (480 J/cm2) for 90 minutes. | 0 | 10 | 0 | 10 | 2 | 10 |
| EG005 | Mock Irradiation Group 3 | Thirty subjects will be 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. Mock irradiation group 3: Received mock phototherapy for 90 minutes. | 0 | 10 | 0 | 10 | 0 | 10 |
| Localized Facial Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D017437 | Skin and Connective Tissue Diseases |
| Incision Sites |
|
|
| 1 month |
|
|
| 3 months |
|
|
| 6 months |
|
|
| Incision Sites |
|
|
| 1 month |
|
|
| 3 months |
|
|
| 6 months |
|
|
| Incision Sites |
|
|
| 1 month |
|
|
| 3 months |
|
|
| 6 months |
|
|
| Incision Sites |
|
|
| 1 month |
|
|
| 3 months |
|
|
| 6 months |
|
|
| localized facial swelling |
|
| no adverse events |
|
| Incision Sites |
|
|
| 1 month |
|
|
| 3 months |
|
|
| 6 months |
|
|