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

State University of New York - Downstate Medical Center

Status and phase: Completed; Phase 2

Conditions: Keloid; Skin Scarring; Hypertrophic Scar; Fibrosis; Scar; Skin Wound

Treatments: Device: Mock irradiation; Device: LED-RL phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03795116

1304108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

LED-RL phototherapy

Experimental group

Description:

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.

Treatment:

Device: LED-RL phototherapy

Mock irradiation

Sham Comparator group

Description:

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.

Treatment:

Device: Mock irradiation