Safety of light emitting diode‐red light on human skin: Two randomized controlled trials. Issue 3 (8th December 2019)

• Record Type: Journal Article
• Authors: Jagdeo, Jared; Nguyen, Julie K.; Ho, Derek; Wang, Erica B.; Austin, Evan; Mamalis, Andrew; Kaur, Ramanjot; Kraeva, Ekaterina; Schulman, Joshua M.; Li, Chin‐Shang; Hwang, Samuel T.; Wun, Ted; Maverakis, Emanual; Isseroff, R. Rivkah
• Is Part Of: Journal of biophotonics. Volume 13:Issue 3(2020)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-12-08
• Subjects: low‐level light therapy -- phototherapy -- randomized controlled trial -- skin pigmentation; Photonics -- Periodicals; Optical materials -- Periodicals; Optics -- Periodicals; Medical instruments and apparatus -- Periodicals; 621.3605
• DOI: 10.1002/jbio.201960014
• Languages: English
• ISSNs: 1864-063X

Abstract

Abstract: Therapeutic applications of light emitting diode‐red light (LED‐RL) are expanding, yet data on its clinical effects are lacking. Our goal was to evaluate the safety of high fluence LED‐RL (≥160 J/cm 2 ). In two phase I, single‐blind, dose escalation, randomized controlled trials, healthy subjects received LED‐RL or mock irradiation to the forearm thrice weekly for 3 weeks at fluences of 160‐640 J/cm 2 for all skin types (STARS 1, n = 60) and at 480‐640 J/cm 2 for non‐Hispanic Caucasians (STARS 2, n = 55). The primary outcome was the incidence of adverse events (AEs). The maximum tolerated dose was the highest fluence that did not elicit predefined AEs. Dose‐limiting AEs, including blistering and prolonged erythema, occurred at 480 J/cm 2 in STARS 1 (n = 1) and 640 J/cm 2 in STARS 2 (n = 2). AEs of transient erythema and hyperpigmentation were mild. No serious AEs occurred. We determined that LED‐RL is safe up to 320 J/cm 2 for skin of color and 480 J/cm 2 for non‐Hispanic Caucasian individuals. LED‐RL may exert differential cutaneous effects depending on race and ethnicity, with darker skin being more photosensitive. These findings may guide future studies to evaluate the efficacy of LED‐RL for the treatment of various diseases. Abstract : Light emitting diode (LED) technology has therapeutic applications for a wide range of medical conditions. These are the first clinical investigations into the safety of LED‐red light (LED‐RL) on human skin at fluences above 160 J/cm 2 . In two phase I, single‐blind, dose escalation, randomized controlled trials, we found that LED‐RL is safe up to 320 J/cm 2 for skin of color and 480 J/cm 2 for non‐Hispanic Caucasian individuals. High fluence LED‐RL may exert differential cutaneous effects depending on race and ethnicity.