NCT03795116

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: State University of New York - Downstate Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-10-26
• Completion: 2020-10-26
• First posted: 2019-01-07
• Last updated: 2022-06-01
• Results posted: 2022-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study