Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Sponsor: State University of New York - Downstate Medical Center
Listed as NCT03795116, this PHASE2 trial focuses on Fibrosis and Hypertrophic Scar and remains completed. Sponsored by State University of New York - Downstate Medical Center, it has been updated 8 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jul 2022 — Jul 2024 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Jan 2021 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
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Sep 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
▶ Show 3 earlier versions
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Dec 2019 — Sep 2020 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Apr 2019 — Dec 2019 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Feb 2019 — Apr 2019 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- State University of New York - Downstate Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .