Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention

Fibrosis Clinical Trial

Official title:

Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795116
• Other study ID #: 1304108
• Status: Completed
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: October 26, 2020

Study information

• Verified date: May 2022
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Fibrosis
• Hypertrophic Scar
• Keloid
• Scar
• Skin Scarring
• Skin Wound

Intervention

Device:
• LED-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.
• 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.

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	1 month, 3 months, 6 months
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).	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	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).
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.	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.	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 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).
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.	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.	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.	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.	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.	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).	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).