Safety of light emitting diode-red light on human skin: Two randomized controlled trials.

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/cm2 ). 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/cm2 for all skin types (STARS 1, n = 60) and at 480-640 J/cm2 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/cm2 in STARS 1 (n = 1) and 640 J/cm2 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/cm2 for skin of color and 480 J/cm2 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.

Successful Treatment of Keloid With Fractionated Carbon Dioxide (CO2) Laser and Laser-Assisted Drug Delivery of Triamcinolone Acetonide Ointment in an African-American Man.

Keloids are fibrous growths that occur as a result of abnormal response to dermal injury. Keloids are cosmetically disfiguring and may impair function, often resulting in decreased patient quality-of-life. Treatment of keloids remains challenging, and rate of recurrence is high. We present a case of a 39-year-old African-American man (Fitzpatrick VI) with a 10-year history of keloid, who was successfully treated with eight sessions of fractionated carbon dioxide (CO2) laser immediately followed by laser-assisted drug delivery (LADD) of topical triamcinolone acetonide (TAC) ointment and review the medical literature on fractionated CO2 laser treatment of keloids. To the best of our knowledge, this is the first report of successful treatment of a keloid using combination therapy of fractionated CO2 laser and LADD with topical TAC ointment in an African-American man (Fitzpatrick VI) with excellent cosmetic results sustained at 22 months post-treatment. We believe that this combination treatment modality may be safe and efficacious for keloids in skin of color (Fitzpatrick IV-VI) and other patients. This case highlights the ability of laser surgeons to safely use fractionated CO2 lasers in patients of all skin colors.

J Drugs Dermatol. 2017;16(9):925-927.

A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial.

BACKGROUND: Skin fibrosis is involved in a variety of pathologic conditions ranging from scar formation secondary to surgery or trauma to immune-mediated processes. Skin fibrosis is a significant international health problem with an estimated incidence of greater than 100 million people affected per year worldwide with few effective treatment options available. Preliminary in vitro data generated by our research group suggests that red light can function as a stand-alone treatment for skin fibrosis. To our knowledge, no prior clinical trials have been performed to determine the safety of high-fluence (dose) light-emitting diode-red light (LED-RL) phototherapy. The goal of this study is to evaluate the safety of LED-RL fluences from 160 J/cm(2) up to 640 J/cm(2) in healthy subjects. METHODS/DESIGN: This is a single-blind, dose escalation, randomized controlled, phase I study to evaluate the safety of high-fluence LED-RL on human skin. The protocol for dose escalation requires subjects be enrolled sequentially in groups of five. Within each group, three subjects will be randomized to LED-RL phototherapy and two subjects randomized to mock therapy. Subjects in group 1 randomized to LED-RL phototherapy will receive the maximum recommended starting dose (160 J/cm(2)). LED-RL dose will be escalated in subsequent groups (320 J/cm(2), 480 J/cm(2) and 640 J/cm(2)). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered to be the upper limit of subject tolerance. After either a MTD has been established, or the study endpoint of 640 J/cm(2) has been achieved, an additional 27 LED-RL phototherapy subjects (for a total of 30) and 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled. Each subject will receive a total of nine procedures, three times per week for three consecutive weeks. DISCUSSION: This study may provide important safety information on the effects of high-fluence LED-RL phototherapy on human skin and help facilitate future phase II studies to evaluate the efficacy of high-fluence LED-RL as a potential noninvasive, safe, portable, at-home therapy for treatment of skin fibrosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT02630303 . Registered on 9 December 2015.

Successful Treatment of Rhinophyma With Fractionated Carbon Dioxide (CO2) Laser in an African-American Man: Case Report and Review of Literature of Fractionated CO2 Laser Treatment of Rhinophyma.

Rhinophyma, a late complication of rosacea (phymatous subtype), is a chronic, progressive dermatological condition. The classic pre- sentation of rhinophyma is nodular, thickened skin over the distal nose, and is often accompanied by underlying erythema secondary to in ammation. Due to the unpleasant aesthetic and dis guring appearance, rhinophyma may be associated with a signi cant nega- tive psychosocial impact, resulting in decreased patient quality-of-life. Treatment of rhinophyma is challenging as topical and systemic pharmacotherapies have shown limited ef cacy. We present a case of a 39-year-old African-American male with long-standing, mild rhinophyma who was successfully treated with two sessions of fractionated carbon dioxide (CO2) laser. We also review the medical literature on fractionated CO2 laser treatment of rhinophyma. To the best of our knowledge, this is the rst report of successful treat- ment of rhinophyma using fractionated CO2 laser in an African-American man (Fitzpatrick VI). We believe that fractionated CO2 laser may be a safe and ef cacious treatment modality for rhinophyma in skin of color patients (Fitzpatrick IV-VI) and early intervention with fractionated CO2 laser to prevent rhinophyma worsening may yield better results than late intervention. J Drugs Dermatol. 2016;15(11):1465-1468..

Isoflurane exposure in newborn rats induces long-term cognitive dysfunction in males but not females.

Volatile anesthetics are used widely for achieving a state of unconsciousness, yet these agents are incompletely understood in their mechanisms of action and effects on neural development. There is mounting evidence that children exposed to anesthetic agents sustain lasting effects on learning and memory. The explanation for these behavioral changes remains elusive, although acute neuronal death after anesthesia is commonly believed to be a principal cause. Rodent models have shown that isoflurane exposure in newborns induces acute neuroapoptosis and long-term cognitive impairment. However, the assessment of predisposing factors is lacking. We investigated the role of sex by delivering isoflurane to postnatal day (P)7 male and female Sprague Dawley rats for 4 h. Brain cell death was assessed 12 h later using FluoroJade C staining in the thalamus, CA1-3 regions of hippocampus, and dentate gyrus. Behavior was assessed separately using a series of object recognition tasks and a test of social memory beginning at P38. We found that isoflurane exposure significantly increased neuronal death in each brain region with no difference between sexes. Behavioral outcome was also equivalent in simple novel object recognition. However, only males were impaired in the recognition of objects in different locations and contexts. Males also exhibited deficient social memory while females were intact. The profound behavioral impairment in males relative to females, in spite of comparable cell death, suggests that males are more susceptible to long-term cognitive effects and this outcome may not be exclusively attributed to neuronal death.