PMID- 31483941 OWN - NLM STAT- MEDLINE DCOM- 20210623 LR - 20220531 IS - 1864-0648 (Electronic) IS - 1864-063X (Print) IS - 1864-063X (Linking) VI - 13 IP - 3 DP - 2020 Mar TI - Safety of light emitting diode-red light on human skin: Two randomized controlled trials. PG - e201960014 LID - 10.1002/jbio.201960014 [doi] AB - 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. CI - (c) 2019 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. FAU - Jagdeo, Jared AU - Jagdeo J AUID- ORCID: 0000-0002-7619-7650 AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Nguyen, Julie K AU - Nguyen JK AD - Department of Dermatology, The State University of New York Downstate Medical Center, Brooklyn, New York. AD - Dermatology Service, VA New York Harbor Healthcare System Brooklyn Campus, Brooklyn, New York. FAU - Ho, Derek AU - Ho D AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Wang, Erica B AU - Wang EB AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Austin, Evan AU - Austin E AD - Department of Dermatology, University of California, Davis, Sacramento, California. FAU - Mamalis, Andrew AU - Mamalis A AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Department of Dermatology, The State University of New York Downstate Medical Center, Brooklyn, New York. FAU - Kaur, Ramanjot AU - Kaur R AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Kraeva, Ekaterina AU - Kraeva E AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Schulman, Joshua M AU - Schulman JM AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. FAU - Li, Chin-Shang AU - Li CS AD - Department of Public Health Sciences, Division of Biostatistics, University of California, Davis, Sacramento, California. FAU - Hwang, Samuel T AU - Hwang ST AD - Department of Dermatology, University of California, Davis, Sacramento, California. FAU - Wun, Ted AU - Wun T AD - Division of Hematology & Oncology, Department of Internal Medicine, University of California, Davis, Sacramento, California. AD - Division of Hematology & Oncology, Sacramento VA Medical Center, Mather, California. AD - UC Davis Clinical and Translational Sciences Center, Sacramento, California. FAU - Maverakis, Emanual AU - Maverakis E AD - Department of Dermatology, University of California, Davis, Sacramento, California. FAU - Isseroff, R Rivkah AU - Isseroff RR AD - Department of Dermatology, University of California, Davis, Sacramento, California. AD - Dermatology Service, Sacramento VA Medical Center, Mather, California. LA - eng GR - K23 GM117309/GM/NIGMS NIH HHS/United States GR - K23GM117309/NH/NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20191208 PL - Germany TA - J Biophotonics JT - Journal of biophotonics JID - 101318567 SB - IM MH - Humans MH - Light MH - *Low-Level Light Therapy MH - Single-Blind Method MH - *Skin/radiation effects PMC - PMC8887049 MID - NIHMS1781281 OTO - NOTNLM OT - low-level light therapy OT - phototherapy OT - randomized controlled trial OT - skin pigmentation EDAT- 2019/09/05 06:00 MHDA- 2021/06/24 06:00 PMCR- 2022/03/01 CRDT- 2019/09/05 06:00 PHST- 2019/06/26 00:00 [received] PHST- 2019/08/31 00:00 [revised] PHST- 2019/09/01 00:00 [accepted] PHST- 2019/09/05 06:00 [pubmed] PHST- 2021/06/24 06:00 [medline] PHST- 2019/09/05 06:00 [entrez] PHST- 2022/03/01 00:00 [pmc-release] AID - 10.1002/jbio.201960014 [doi] PST - ppublish SO - J Biophotonics. 2020 Mar;13(3):e201960014. doi: 10.1002/jbio.201960014. Epub 2019 Dec 8.