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

NCT ID: NCT03795116

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2020-10-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LED-RL phototherapy

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.

Group Type: EXPERIMENTAL

LED-RL phototherapy

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Mock irradiation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Omnilux handheld LED system (GlobalMed Technologies, Glen Ellen, CA)

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jared Jagdeo, MD, MS

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SUNY Downstate Medical Center

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31307501 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1304108

Identifier Type: -

Identifier Source: org_study_id