178 JOURNAL OF COSMETIC SCIENCE species. For the skin, the consequences of this imbalance include inflammation, photo­ toxicity, loss of function, accelerated aging, and skin cancer (1,2). As the first line of defense against noxious environmental factors, nature has endowed the skin with a sophisticated antioxidant defense system (3,4). Ascorbic acid (vitamin C) is the most abundant antioxidant in the epidermis (5,6). However, vitamin E (tocopherol) may be the most important because it is present in limited quantities, humans cannot synthesize it, it is readily depleted by UV radiation (7) and other oxidative stresses such as ozone (8), and it is the dominant antioxidant responsible for protecting the stratum corneum lipids from oxidation (9, 10). Since dietary intake represents the sole means of obtaining this critical nutrient, the Institute of Medicine of the National Academies recently increased the recommended dietary intake (RDI) levels from 12 mg to 15 mg per day for adults (11). Indeed, data from the Third National Health and Nutrition Examination Survey (12) suggest that approximately 27% of the adults in the US exhibit low serum a-tocopherol levels ( 20 µmol/liter). Since the correlation between diet and skin a-tocopherol levels is reasonably strong (13,14), one might infer from this study that the skin of these individuals may be deficient in vitamin E and underprotected against oxidative stress. One attractive solution to environmentally induced skin vitamin E deficiency is topical supplementation (15,16). Indeed, numerous consumer products claim to deliver vitamin E (and other ingredients) to the skin. However, clinical evidence supporting these claims is limited to several studies at best (17-21). Not surprisingly, consumers are even more skeptical when cleansing products claim to deliver an ingredient (22), largely because these products were designed to remove soil. In this report we show that a brief exposure to natural sunlight depletes stratum corneum vitamin E, creating a functional deficiency. Moreover, we provide clinical evidence to document the performance of a newly developed cleansing product that delivers more vitamin E to skin than could be achieved through dietary supplementation with a vitamin E tablet. SUBJECTS AND METHODS STUDY OBJECTIVES The primary objective of this research was to determine the impact of natural sunlight on vitamin E in the superficial layer of the stratum corneum (SC) and to determine if a skin cleansing product containing vitamin E delivered more vitamin E to the skin than dietary supplementation. All protocols were reviewed internally by a protocol review committee and when necessary were reviewed and approved by an external IRB (Con­ cordia Research Laboratories, Cedar Knolls, NJ). SUBJECT POPULATION AND STUDY DESIGN Female subjects, ages 38-61 years (mean 48 years), with no known allergies, preexisting medical (i.e., pregnancy/nursing, hypertension, diabetes, etc.) or active skin conditions (i.e., skin cancer, acne, psoriasis, atopic dermatitis, etc.) were eligible for entry. In addition to the above requirements, participants in the sunlight exposure study also met

VITAMIN E DELIVERY BY SKIN CLEANSER 179 the following requirements: They were Caucasians with moderate pigmentation (Fitz­ patrick skin types II-III), and successfully completed a physical examination by a board­ certified dermatologist. Last, but not least, all panelists agreed to avoid excessive expo­ sure to the sun and to use only the products (cf. below) provided to them by the study monitor. All subjects underwent one week of preconditioning (normalization) with commercially available cleansing products that lacked vitamin E or vitamin E acetate (or any esters of vitamin E) and were entered into the studies after they had satisfied all inclusions/ exclusions. EFFECTS OF SUNLIGHT ON VITAMIN E IN THE SUPERFICIAL SC Forearms were exposed to 30 ± 1 minutes of midday sunlight in Somerset County, NJ (latitude 40° north) in August and in a second study in October 2000. All subjects faced south (180° from magnetic north using a certified compass). The relative proportions of UVB/A were determined using a radiometer (UVP, Inc., San Gabriel, CA) fitted with 310-nm and 365-nm probes. Six measurements were taken between 11AM and 2PM and used to calculate a mean solar irradiance value. Prior to exposure, an unexposed control site close to the flex was extracted to obtain baseline vitamin E values (time = 0 h). This site was then covered with aluminum foil and wrapped loosely with surgical gauze. The other forearm was left uncovered, and both forearms were subsequently exposed to sunlight. After 30 ± 1 minutes of exposure but prior to vitamin extraction (described below), an expert grader evaluated each site for erythema using a five-point scale (0 = no redness to 4 = fiery red). TOPICAL VERSUS DIETARY SUPPLEMENTATION To determine which of two modalities, oral supplementation or topical application, was more effective in increasing vitamin E in the superficial SC, 21 healthy female subjects (ages 18-55) were enrolled in a double-blind, vehicle-controlled study and divided into two groups: topical (n = 11) and dietary (n = 10). The topical group was washed with the vitamin E body wash, whereas the dietary group was washed with a matched vehicle body wash that did not contain vitamin E or vitamin E acetate. In addition to having their forearms washed with the placebo cleanser, subjects in the dietary groups were given a vitamin E tablet (400 IU a-tocopherol) to be taken orally each day for 11 days, including one Saturday and Sunday that fell between the two work weeks in the study (Table I). In the topical group, the forearms were not washed on that Saturday and Sunday. Both groups continued using the preconditioning products (i.e., products lack­ ing vitamin E and vitamin E acetate) provided to them during this time. Skin and blood samples were collected for vitamin analysis prior to any treatment on day 1 and imme­ diately after dietary supplementation or washing the skin with the test product on day 11. SKIN WASHING PROCEDURE The appropriate sites on the forearm skin were washed once with the body wash vehicle or vitamin E body wash (cf. below). Trained technicians wearing polyethylene gloves