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      Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients : A Randomized Clinical Trial

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          Abstract

          The US Food and Drug Administration (FDA) has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies.

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          Sunscreens: are they beneficial for health? An overview of endocrine disrupting properties of UV-filters.

          N Skakkebaek, M Schlumpf, T Søeborg … (2012)
          Today, topical application of sunscreens, containing ultraviolet-filters (UV-filters), is preferred protection against adverse effects of ultraviolet radiation. Evidently, use of sunscreens is effective in prevention of sunburns in various models. However, evidence for their protective effects against melanoma skin cancer is less conclusive. Three important observations prompted us to review the animal data and human studies on possible side effects of selected chemical UV-filters in cosmetics. (1) the utilization of sunscreens with UV-filters is increasing worldwide; (2) the incidence of the malignant disorder for which sunscreens should protect, malignant melanoma, is rapidly increasing and (3) an increasing number of experimental studies indicating that several UV-filters might have endocrine disruptive effects. The selected UV-filters we review in this article are benzophenone-3 (BP-3), 3-benzylidene camphor (3-BC), 3-(4-methyl-benzylidene) camphor (4-MBC), 2-ethylhexyl 4-methoxy cinnamate (OMC), Homosalate (HMS), 2-ethylhexyl 4-dimethylaminobenzoate (OD-PABA) and 4-aminobenzoic acid (PABA). The potential adverse effects induced by UV-filters in experimental animals include reproductive/developmental toxicity and disturbance of hypothalamic-pituitary-thyroid axis (HPT). Few human studies have investigated potential side effects of UV-filters, although human exposure is high as UV-filters in sunscreens are rapidly absorbed from the skin. One of the UV-filters, BP-3, has been found in 96% of urine samples in the US and several UV-filters in 85% of Swiss breast milk samples. It seems pertinent to evaluate whether exposure to UV-filters contribute to possible adverse effects on the developing organs of foetuses and children. © 2012 The Authors. International Journal of Andrology © 2012 European Academy of Andrology.
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            Quality of life in patients with chronic urticaria is differentially impaired and determined by psychiatric comorbidity.

            P Staubach, A. Eckhardt-Henn, M Dechene … (2006)
            Chronic urticaria (CU), one of the most common skin disorders, is characterized by spontaneous recurrent bouts of weals and pruritus and associated with severely impaired quality of life (QoL). To determine what aspects of life quality are affected and to characterize the factors that impact on QoL in CU patients. This interdisciplinary interview/questionnaire-based study included 100 patients admitted to a University Hospital Dermatology Department for the identification of underlying causes of CU; 96 healthy subjects matched for age and sex were used as controls. QoL was assessed using Skindex-29, a validated instrument to measure the effects of skin disease on overall QoL (composite score) and three defined QoL aspects (emotions, symptoms, functioning). CU patients exhibited markedly reduced overall QoL compared with healthy control subjects. CU had distinct effects on the three QoL aspects assessed (functioning = emotions > symptoms). The age or sex of patients, the absence or presence of angio-oedemas, and the duration or cause of CU did not significantly influence QoL impairment. Interestingly, psychiatric comorbidity (depression, anxiety, somatoform disorders) was associated with a more pronounced reduction of QoL compared with CU patients without a psychiatric diagnosis and the severity of psychiatric disease was found to correlate with QoL impairment. Our data confirm that overall QoL is markedly reduced in CU patients. Social functioning and emotions were found to be the areas of QoL most affected in CU patients. Psychiatric comorbidity significantly increased QoL impairment, whereas QoL in CU patients was not significantly affected by age or sex, the absence or presence of angio-oedema, or the course or cause of CU.
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              Sunscreens in human plasma and urine after repeated whole-body topical application.

              N Janjua, H Wulf, B Kongshoj … (2008)
              The three chemical ultraviolet absorbers benzophenone-3 (BP-3), octyl-methoxycinnamate (OMC) and 3-(4-methylbenzylidene) camphor (4-MBC) are commercially used in sunscreens worldwide. Apart from sun protection, they may possess endocrine-disrupting effects in animals and in vitro. For all three compounds, only sporadic measurements of percutaneous absorption and excretion after topical application in humans have been described. In this study, 32 healthy volunteers, 15 young males and 17 postmenopausal females, were exposed to daily whole-body topical application of 2 mg/cm(2) of sunscreen formulation at 10% (w/w) of each for 4 days. Blood concentrations were measured at 0, 1, 2, 3, 4, 24 and 96 h and urine concentrations at 0, 24, 48, 72 and 96 h. Almost all three sunscreens were undetectable in plasma and urine before the first application. One to 2 h after the first application, all three sunscreens were detectable in plasma. The maximum median plasma concentrations were 187 ng/mL BP-3, 16 ng/mL 4-MBC and 7 ng/mL OMC for females and 238 ng/mL BP-3, 18 ng/mL 4-MBC and 16 ng/mL OMC for men. In the females, urine levels of 44 ng/mL BP-3 and 4 ng/mL of 4-MBC and 6 ng/mL OMC were found, and in the males, urine levels of 81 ng/mL BP-3, 4 ng/mL of 4-MBC and OMC were found. In plasma, the 96-h median concentrations were higher compared with the 24-h concentrations for 4-MBC and OMC in men and for BP-3 and 4-MBC in females.
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                Author and article information

                Journal
                Title: JAMA
                Abbreviated Title: JAMA
                Publisher: American Medical Association (AMA)
                ISSN (Print): 0098-7484
                Publication date (Electronic): May 06 2019
                Affiliations
                [1 ]Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
                [2 ]Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
                [3 ]Spaulding Clinical Research, West Bend, Wisconsin
                [4 ]Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
                [5 ]Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
                Article
                DOI: 10.1001/jama.2019.5586
                PMC ID: 6549296
                PubMed ID: 31058986
                SO-VID: 34113a33-becc-4e62-8be3-a54936198866
                Copyright © © 2019
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