Histological and Gene Expression Analysis of the Effects of Menopause Status and Hormone Therapy on the Vaginal Introitus and Labia Majora.

BACKGROUND: The study aimed to determine the effect of menopausal status and hormone therapy on the introitus and labia majora at the levels of histology and gene expression. METHODS: Three cohorts of 10 women each (pre-menopause, post-menopause and post-menopause + hormone therapy) were selected based on the presentation of clinical atrophy and vaginal pH. Biopsies were obtained from the introitus (fourchette) and labia majora and processed for histology and gene expression analyses with microarrays. Other data collected included self-assessed symptoms, serum estradiol, testosterone, serum hormone binding globulin and the pH of the vagina and labia majora. RESULTS: The introitus appears exquisitely sensitive to hormone status. Dramatic changes were observed in histology including a thinning of the epithelium in post-menopausal subjects with vaginal atrophy. Furthermore, there was differential expression of many genes that may contribute to tissue remodeling in the atrophic introitus. Levels of expression of genes associated with wound healing, angiogenesis, cell migration/locomotion, dermal structure, apoptosis, inflammation, epithelial cell differentiation, fatty acid, carbohydrate and steroid metabolism were significantly different in the cohort exhibiting atrophy of the introitus. While changes were also observed at the labia, that site was considerably less sensitive to hormone status. The gene expression changes observed at the introitus in this study were very similar to those reported previously in the atrophic vagina providing further evidence that these changes are associated with atrophy. CONCLUSIONS: The histological and gene expression changes occurring within the introitus after menopause may contribute to the constellation of symptoms that constitute the genitourinary syndrome of menopause.

The Prevalence of Sensitive Skin.

Sensitive skin has been described as unpleasant sensory responses to stimuli that should not provoke such sensations. Objectively measurable signs of irritation are not always present in individuals with sensitive skin, however, subjective sensory effects such as, itching, burning, stinging, tightness, and dryness, are consistently present. Given the subjective nature of the phenomenon known as sensitive skin, surveys have been a popular approach to evaluating the prevalence of this condition among the general population, and a number of them have been conducted worldwide. Overall, ~60-70% of women and 50-60% of men report having some degree of sensitive skin. However, there are differences between populations in various geographies, and perceptions of sensitive skin at specific anatomic sites. This article is a review of survey data on the prevalence of self-declared sensitive skin in various geographies, among different gender and age groups, and at various anatomic sites. In addition, we review the factors that may contribute to sensitive skin, and the physiological characteristics associated with this condition, including impaired barrier function and heightened neural reactions.

Sensitive Skin in the Genital Area.

When evaluating sensitive skin, it is common to focus on the face. However, it is becoming increasingly clear that individuals can have different perceptions about the degree of skin sensitivity at distinct anatomic sites. Structural variations in the skin of different body sites can contribute to differences in barrier function, which may contribute to differences in skin sensitivity. Potential triggering factors for skin sensitivity would be expected to vary by body site. For example, the face is exposed to all ambient environmental conditions in the course of daily life, and to several products (e.g., cosmetics for women) and practices (e.g., shaving for men) that may lead to adverse sensations associated with sensitive skin. In contrast, the skin of the genital area is protected from ambient environmental conditions. However, the genital area can be exposed to conditions of higher temperature, different habits and practices and moisture due to the semi-occlusive environment. For some individuals, additional challenges such as incontinence can provide triggering factors for skin sensitivity that effect only the genital area. This article reviews data on the perception of sensitive skin of the genital area, differences based on gender, age, racial differences, and the effects of incontinence on skin sensitivity. The effects of menopause are also considered with regards to sensitive skin perceptions and to emerging differences in biomolecular and physical measures of the urogenital skin.

Clinical Skin Mildness Evaluations of Direct and Indirect Exposure to Two Commercial Laundry Detergents with Markedly Different pH Designed for Sensitive Skin Using a Hand-Laundering Model.

The skin mildness of two commercial laundry detergents designed for sensitive skin, Tide Free and Gentle® (TFG) versus All Free Clear® (AFC), was compared in clinical studies, and the role of marked product pH differences was assessed. Two double-blind randomized human studies were conducted. Study 1 was a 1-day repeat insult forearm test, in which four exposures to solutions of TFG or AFC were performed to mimic direct exposure to dilute detergent during hand-laundering. Corneometer, erythema and dryness grading, transepidermal water loss (TEWL), and skin surface pH evaluations were carried out. Study 2 was a 21-day arm patch test of fabrics washed with TFG or AFC to mimic indirect contact to skin of detergent residues, with erythema grading. Separately, pH and reserve alkalinity were determined for each detergent. In Study 1, TFG was significantly milder than AFC in all measures except TEWL (no significant difference). In Study 2, the detergents were approximately equivalent in erythema grading. Analysis showed AFC was substantially more alkaline (pH 10.8) than TFG (pH 7.9) with higher reserve alkalinity. TFG was significantly milder than AFC in Study 1, which may be due in part to the increased skin surface pH seen with direct exposure to AFC's high alkalinity.

Comparison of the Vaginal Microbiomes of Premenopausal and Postmenopausal Women.

For decades hormone therapy (HT) has been prescribed to treat the symptoms of menopause, such as vaginal dryness, itching and burning. Here we sought to compare the vaginal microbiomes of postmenopausal women who received low dose estrogen therapy to those of premenopausal and postmenopausal women, and to do so in conjunction with assessing the alleviation of symptoms associated with vaginal atrophy. In this study vaginal swab samples were obtained from 45 women who were classified as either premenopausal, postmenopausal, or postmenopausal and undergoing HT. The vaginal microbiomes of these women were characterized by 16S rRNA gene sequencing and bacterial abundances were quantified by qPCR. We found that the vaginal communities from our cohort could be divided into six clusters (A-F) based on differences in the composition and relative abundances of bacterial taxa. Communities in cluster A were dominated by Lactobacillus crispatus, and those of cluster B were dominated by Gardnerella vaginalis. Communities in cluster C had high proportions of L. iners, while those in cluster D were more even and included several co-dominant taxa. Communities in clusters E and F were dominated by Bifidobacterium and L. gasseri, respectively. The vaginal communities of most postmenopausal women receiving HT (10/15) were dominated by species of lactobacilli and belonged to clusters A, C, and F (P < 0.001). This sharply contrasts with vaginal communities of postmenopausal women without HT, most of which (10/15) were in cluster D, depleted of lactobacilli, and had about 10-fold fewer total bacteria (P < 0.05). The vaginal communities of women in each study group differed in terms of the dominant bacterial species composition and relative abundance. Those of postmenopausal women receiving HT significantly differed from those of postmenopausal women without HT and were most often dominated by species of Lactobacillus. Noteworthy, HT greatly improved vaginal atrophy scores, decreased vaginal pH, and significantly increased bacterial numbers in comparison to postmenopausal women not receiving HT.

Intrinsic and Extrinsic Factors Affecting Skin Surface pH.

The body skin pH can usually vary from 4.0 to 7.0 depending on location. The presence of natural acidic compounds on the skin surface helps maintain the skin's physicochemical properties as well as its protective functions. Since the slightly acidic pH of the skin is extremely important for the skin's protective function, the skin is widely known as "acid mantel." Factors such as age, race, gender, body sites, biochemical differences, and even washing affect the pH of the stratum corneum. Recent clinical studies using an emollient-base finish product using the traditional way of measuring skin pH produced results that indicated an apparent increase in skin pH. The apparent pH increase with these products is most probably an artifact of the skin pH measurement technique. Our findings show that certain petrolatum-based emollients and components could create a protective barrier and help maintain the healthy acidity of the skin. Our work provides new evidence of emollients helping to stabilize skin pH in its natural balanced state rather than affecting it. This new learning should be taken into consideration by other researchers in the area of skin pH as well as in clinical studies to avoid misleading results.

Visible-Near Infrared Spectroscopic Assessment of Urogenital Tissue in Premenopausal and Postmenopausal Women.

BACKGROUND: A clinical study was conducted to evaluate the feasibility of using visible and near-infrared (NIR) spectroscopy as a potential noninvasive measure of genital skin health in premenopausal and postmenopausal women. METHODS: A total of 45 female subjects (aged 21-70 years), all of whom gave fully informed consent to participate, were enrolled in the study and assigned to 1 of 3 groups: 15 premenopausal (Pre-M), 15 postmenopausal receiving hormone replacement therapy (Post-M HRT), and 15 postmenopausal receiving no form of hormone replacement therapy (Post-M non-HRT). Spectral measurements were taken at the vaginal mucosa, and spectral data were evaluated for the erythema index (EI), hemoglobin index (HI), bilirubin/ß-carotene, and melanin. The color index (CI; calculated as the ratio of absorbance at 480 nm/540 nm) was also determined. Results were compared with previously published results on biomarkers and physical characteristic of genital tissue measured on the same groups of women. RESULTS: Spectral measurements from the Post-M Non-HRT subjects indicated a significant reduction in HI compared with the Pre-M group (P = .0003) and to the Post-M HRT group (P < .0001). Similarly, EI was reduced in the Post-M Non-HRT (P < .0001 and P = .0041 for the Pre-M and Post-M HRT groups, respectively). In contrast, the Post-M Non-HRT subjects exhibited a significant increase in ß-carotene compared with the Pre-M subjects (P = .0098). Bilirubin and melanin were not significantly affected. The Post-M Non-HRT group exhibited a significant increase in CI, indicating a shift away from the hemoglobin absorption region (510-620 nm wavelength) and toward the bilirubin/ß-carotene absorption region (450-490 nm wavelength). This change was significant when compared with both the Pre-M group (P < .0001) and the Post-M HRT group (P = .0048). The changes in spectral measurements were consistent with previously reported changes in physical parameters (vaginal atrophy, increased pH, decreased skin temperature) and with decreased concentrations of the biomarkers histamine and histidine. CONCLUSIONS: Hemodynamic spectral characteristics differ in postmenopausal vaginal tissue compared with tissue in premenopausal women, with decreased absorbance in the hemoglobin absorption region (510-620 nm wavelength) and an increased absorbance in the bilirubin/ß-carotene absorption region (450-490 nm wavelength). A change in absorbance in the visible and NIR wavelengths is a promising, additional measure of genital skin health related to menopause and vulvovaginal atrophy.

Specific dermatological benefits associated with quantities of lotion transferred to the skin.

BACKGROUND: A growing number of manufacturers are taking advantage of the ability of absorbent consumer products to deliver lotion to the skin. The lotion is included on these products to help protect the skin from adverse skin effects that can occur, including: (1) irritation, (2) over hydration of the stratum corneum, (3) dryness that can occur from extended exposure to highly absorbent consumer products, and (4) changes in pH. OBJECTIVE: This manuscript presents results of a quantitative lotion transfer study of adult incontinence products. Resulting lotion transfer is compared to the results of several separate experiments in which specific skin benefits have been correlated to lotion concentrations. METHODS: The behind-the-knee (BTK) lotion transfer protocol was used to quantitate lotion transfer from adult incontinence (AI) test products constructed using 2 lotion formulations and 2 configurations of lotion application. A modified arm patch protocol, in which skin sites of a measured dimension were pre-treated with specific volumes of lotion, was used to evaluate protective effects of lotion against exposure to irritants, and over hydration from wetted absorbent products. RESULTS: After a 6-hours continuous exposure in the BTK the 5-stripe lotion configuration products transferred (adjusted mean ± SE) 94 ± 11-104 ± 11 µg/cm2 lotion. After 24 hours of wear, transfer had increased to 127 ± 22 and 149 ± 24 µg/cm2 , respectively. The single-block configuration products transferred 289 ± 10-316 ± 10 µg/cm2 (P = .04). Transfer after 24 hours of wear was 328 ± 23 and 472 ± 21 µg/cm2 , respectively (P < .0001). Several protocols were used to evaluate the concentration of lotion required to provide four specific skin benefits. In studies evaluating protection against irritants, skin site pre-treated with lotion were patched with 0.5% sodium lauryl sulfate (SLS). Protective effects were assessed by visual assessment of erythema and trans-epidermal water loss (TEWL). In the first experiment, lotion pre-treatment concentrations as low as 165 µg/cm2 exhibited significantly (P < .05) lower erythema and TEWL compared to the positive irritant control (ie, no lotion pre-treatment and SLS only). In the second experiment, lotion pre-treatment concentrations of 80 µg/cm2 (P = .018) exhibited significantly (P = .018) lower TEWL. In two studies on protection from over hydration, lotion pre-treatment sites were subsequently patched with wetted absorbent consumer products. The change in TEWL was used as a measure of over hydration. Lotion concentrations significantly reduced the increase in TEWL at 80 µg/cm2 (P = .007) and 70 µg/cm2 (P ≤ .05). A BTK study was used to evaluate the ability of lotion to prevent dryness. After 6 hours of wear, test products transferring lotion concentrations of 110 or 133 µg/cm2 produced significantly lower scores for dryness compared to products transferring 48 or 69 µg/cm2 . Using collagen sheets to mimic the stratum corneum, an in vitro study was conducted to measure the ability of lotion to prevent passage of high pH buffer solution. Results demonstrated that the lowest concentration of lotion that was tested (110 µg/cm2 ) interfered with passage of the high pH buffer through the collagen sheet, delaying the rise in pH. CONCLUSIONS: We can conclude that pretreatment with 110 µg/cm2 lotion acts as a barrier to high pH fluids such as urine. Using the measurement of lotion transfer from the AI products, together with the results of studies conducted to determine the concentration of lotion required to provide specific skin benefits, we conclude that the five-stripe lotion configuration AI test products transferred enough lotion (ie, ≥80 µg/cm2 ) to provide skin protection with regard to: (1) irritant effects and (2) excess moisture. The single-block AI test products also transferred enough lotion to provide these skin benefits (ie, ≥165 µg/cm2 ), and the additional benefits of skin protection against: (3) dryness, and (4) changes in pH.

Assessing the dermal compatibility of a new female incontinence product line.

CONTEXT: We have developed a line of products designed to better meet the overall needs of women suffering from urinary incontinence. The products are more discrete and contain a unique odor neutralizing technology (ONT). OBJECTIVE: This paper describes the overall skin compatibility program for this product line in which the new products were compared to negative controls and/or commercially marketed reference products with an established history of safe use. MATERIALS AND METHODS: Test products consisted of several product forms (light pads/pantiliners, moderate pads, briefs and taped diapers) with ONT and having various degrees of protection. Studies were conducted using standard protocols for 4-day and 21-day cumulative irritation, the Human Repeat Insult Patch Test (HRIPT), and the Behind-the-Knee (BTK) test for mechanical and chemical irritation. In one 4-day irritation study and one HRIPT, test subjects consisted of individuals with self-assessed sensitive skin. In addition, one 4-day study was conducted using normal skin sites, and sites compromised by tape stripping. Nonirritant controls were physiologic saline and/or current, commercially marketed incontinence products. All responses were evaluated by visual scoring of erythema. In addition, in the BTK, transepidermal water loss (TEWL) and adverse sensory effects collected from panelists' daily diaries were also evaluated. RESULTS AND DISCUSSION: Two 4-day cumulative irritation studies and one 21-day study demonstrated that a wide range of product forms (liners, light and moderate pads, briefs and adult diapers) produced skin reactions similar to the nonirritant controls. The 4-day study conducted using sensitive skin subjects showed good skin compatibility, and the test products were comparable to the nonirritant controls. In the 4-day study with both normal and compromised skin sites, test products produced mean erythema scores similar to the nonirritant controls. Three HRIPT separate studies confirm that the products do not induce contact sensitization, including one study conducted on individuals with self-assessed sensitive skin. In the BTK, test and control products produced similar irritation, as assessed by erythema, TEWL and sensory effects. CONCLUSION: The results from the patch tests and mechanical irritation test demonstrate good skin compatibility of the new line of products with the unique ONT. In addition, the forms of the product (i.e. liner, pad or brief), were equally compatible with skin.

Female genital cutting: confronting cultural challenges and health complications across the lifespan.

Female genital cutting affects over 140 million women worldwide. Prevalent in certain countries of Africa and the Middle East, the practice continues among immigrants to industrialized countries. Female genital cutting is a deeply rooted tradition that confers honor on a woman and her family, yet also a traumatic experience that creates significant dermatological, gynecological, obstetric and infectious disease complications. Little is known about postmenopausal health in cut women. The international community views this practice as a human rights violation. In addition to genital health complications, the medical community must confront an understudied concern of what happens as this population ages. These challenges must be addressed to provide optimal care to women affected by female genital cutting.

Assessing menstrual tampon irritation using the "Behind-The-Knee" test.

INTRODUCTION: Colposcopic inspection of the vagina is a routine component of the safety assessment of intravaginal products. However, colposcopic findings occur frequently in healthy women, raising questions about their relevance to intravaginal product safety. Practical disadvantages limit the utility of colposcopy for evaluating menstrual tampons, among them the presence of background microtrauma, the inability to assess effects during menstruation, and, importantly, the question of whether post hoc assessments are sufficiently sensitive to detect small inflammatory changes. The Behind-The-Knee (BTK) test is an alternative for evaluating inflammatory and tissue dryness effects of physical articles by their repeated application to the popliteal fossa under an elastic bandage. It enables concurrent parallel comparisons of experimental and control articles over time and substantially increases the sensitivity of detecting small changes in tissue inflammation. MATERIAL AND METHODS: With the protocol, uncompressed experimental and control tampons yielded comparable relative and absolute erythema scores (after overnight recovery) as did colposcopic assessment of the lower genital tract 3-48 h after menstrual use. Scoring erythema in the BTK test immediately after product removal increased the level of visually discernible inflammation sixfold. In a study of commercial menstrual pads, subclinical inflammation visualized with cross-polarized light correlated with the frequency of subjective reports of discomfort during the test and discriminated the relative tolerability of the two products determined by market surveillance, providing added confidence in the predictive value of the test. CONCLUSION: We believe the BTK test can be a valuable alternative to colposcopy for assessing inflammation and dryness associated with menstrual tampons.

Characteristics of the Aging Skin.

SIGNIFICANCE: Although most researches into the changes in skin with age focus on the unwelcome aesthetic aspects of the aging skin, skin deterioration with age is more than a merely cosmetic problem. Although mortality from skin disease is primarily restricted to melanoma, dermatological disorders are ubiquitous in older people with a significant impact on quality of life. The structural and functional deterioration of the skin that occurs with age has numerous clinical presentations, ranging from benign but potentially excruciating disorders like pruritus to the more threatening carcinomas and melanomas. RECENT ADVANCES: The degenerative changes that occur in the aging skin are increasingly understood at both the molecular and cellular level, facilitating a deeper understanding of the structural and functional deterioration that these changes produce. CRITICAL ISSUES: A loss of both function and structural stability in skin proceeds unavoidably as individuals age, which is the result of both intrinsic and extrinsic processes, which contribute simultaneously to a progressive loss of skin integrity. Intrinsic aging proceeds at a genetically determined pace, primarily caused by the buildup of damaging products of cellular metabolism as well as an increasing biological aging of the cells. Estrogen levels strongly influence skin integrity in women as well; falling levels in midlife, therefore, produce premature aging as compared with similarly aged men. Extrinsic insults from the environment add to the dermatological signs of aging. FUTURE DIRECTIONS: A deeper understanding of the physiological basis of skin aging will facilitate progress in the treatment of the unwelcome sequelae of aging skin, both cosmetic and pathogenic.

Design principles to accommodate older adults.

The global population is aging. In many industrial countries, almost one in five people are over age 65. As people age, gradual changes ensue in vision, hearing, balance, coordination, and memory. Products, communication materials, and the physical environment must be thoughtfully designed to meet the needs of people of all ages. This article summarizes normal changes in sensory function, mobility, balance, memory, and attention that occur with age. It presents practical guidelines that allow design professionals to accommodate these changes and better meet the needs of older adults. Designing for older adults is inclusive design: it accommodates a range of physical and cognitive abilities and promotes simplicity, flexibility, and ease of use for people of any age.

Assessing quality of life in older adult patients with skin disorders.

Older adults experience a number of skin diseases and disorders that substantially affect quality of life. In the last two decades, a number of instruments have been developed for use among general dermatology patients to assess the effects of treatment and disease progression, perceptions of well-being, and the value that patients place on their dermatologic state of health. This chapter reviews some health-related quality of life (HRQoL) (HRQoL) measures developed and validated specifically for dermatological conditions. However, opportunity exists for developing and validating HRQoL measures specifically for dermatological conditions most pertinent to older patients.  

Translation and validation of the Farage Quality of Life (FQoL™) instrument for consumer products into traditional Chinese.

The Farage Quality of Life™ questionnaire (FQoL™) was developed specifically to assess the impact of consumer products. The objective of this investigation was to achieve a Chinese language instrument. The FQoL™ underwent a forward and backward translation, with cognitive testing by 13 subjects. Slight modifications were made to the instrument, and an implementation study was conducted with 800 participants having a mean (±SD) age of 34.22 (±9.28) years. The subjects were randomly assigned to use 1 of 4 ultra absorbency pad products for the length of one menstrual cycle. Three pads (coded N, S and C) were products currently available on the retail market, a fourth (coded M) was an experimental product improvement on Product N. Subjects were asked to complete the FQoL™ once before (T1) and once after (T2) the start of their period, and the Least Square (LS) Means were determined. Within group comparisons for each item and FQoL™ subscale were conducted by comparing the LS Means for T1 vs. T2. Participants using Product N showed the highest number of significant (p<0.05) changes (11 items), demonstrating these subjects felt worse about items mainly in the subdomains for Emotions, Personal Pleasure, and Physical State. Participants using Product C showed significant changes in 7 items mainly in the subdomains for Emotion and Physical State. Participants using Product S and the experimental Product M showed significant changes in only 4 and 3 individual items, respectively. These were not associated with any particular domain or subdomain. Between group comparisons were conducted by comparing the LS Means for the T2 responses for each group. The group using Product N had LS Mean responses that were significantly worse than the group using Product M for the Emotion, Personal Pleasure and Physical State subdomains, the Energy/Vitality domain, and 2 individual items. The Product S group was worse than the Product M group for 2 individual items. The Product C group was worse than the Product M group for the Personal Pleasure and Physical State subdomains and 5 individual items. We found that the Chinese language FQoL™ detected changes in HRQoL during menstruation compared with before menstruation. Further, the measure was able to detect differences among groups of subjects using different menstrual protection products.

A Feminine Care Clinical Research Program Transforms Women's Lives.

Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer's well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met.

Dermatological testing of an improved apertured film surface for feminine hygiene pads.

CONTEXT: Apertured polyethylene films (AF) have been used as a surface for sanitary pads for decades because they are compatible with the skin and keep the pad surface drier. A modified film (AF-plus) with improved fluid handling and a smoother, suppler texture has been developed. We hypothesized that these changes would improve both performance and skin compatibility. However, distinguishing the skin effects of materials that are inherently mild is a challenge. OBJECTIVES: (i) To compare the skin irritation potential of pads with AF-plus modified film relative to the standard AF film and (ii) to assess the potential for the AF-plus film to induce delayed contact hypersensitivity. MATERIALS AND METHODS: Pads bearing the AF-plus film were compared to pads with the standard AF film in a behind-the-knee (BTK) test, which assesses the combination of chemical irritation and frictional effects of materials applied to the popliteal fossa under a semi-occlusive bandage. Erythema on the skin surface was scored with the naked eye and subsurface tissue erythema was visualized and scored using cross-polarized illumination. Skin dryness was scored with the naked eye only. One-sided statistical evaluations were performed to test the hypothesis of AF-plus film superiority. The potential of the AF-plus film to induce delayed contact hypersensitivity was assessed by a human repeat insult patch test (HRIPT). RESULTS: Pads with the AF-plus surface were significantly milder to skin in the BTK test, producing lower levels of both surface and subsurface tissue erythema. Moreover, subjects with preexisting erythema on the skin surface at study start developed comparatively less erythema over the course of the study overall with the AF-plus pad compared to the AF pad. No significant difference in skin dryness was observed between product groups. The AF-plus pad showed no evidence of inducing delayed contact hypersensitivity. CONCLUSIONS: The AF-plus pad was superior to the AF pad in terms of skin mildness as discerned by objectively scored surface and subsurface tissue erythema. In subjects with preexisting erythema, the AF-plus pad appeared to contribute less to the further development of inflammation under the test conditions. Given the compositional similarities in the two films, the results could point to more limited contribution of the AF-plus film to skin friction, one of the factors simulated by the BTK test protocol.

Historical perspective on the use of visual grading scales in evaluating skin irritation and sensitization.

Visual assessment of skin reactions has long been used to evaluate the safety of chemicals and preparations that contact the skin, and to meet regulatory requirements. This article reviews the history of visual grading scales, and the results of investigations into the reliability of the method. Some examples are provided to illustrate the diverse array of protocols that use visual scoring to evaluate skin irritation. Furthermore, as bioengineering methods are developed that can quantitate certain aspects of skin irritant and sensitization reactions, it is important to consider whether such measures should supplement or replace visual assessment. Examples of investigations comparing the outcomes of studies that use visual scoring and those that use bioengineering methods are discussed. These examples provide little evidence that bioengineering measures provide an improvement in overall quality in comparison with current testing methods that rely on visual assessment. In addition, such measuring techniques can add considerably to the complexity of testing protocols. When benefits and cost are weighed in the balance, the visual assessment scales popularized by Draize and others remain an effective, practical method of evaluation.

Morphology and physiological changes of genital skin and mucosa.

The morphology and physiology of both the vulva and vagina undergo characteristic age-related changes over a lifetime. At birth, these tissues exhibit the effects of residual maternal estrogens. During puberty, the vulva and vagina mature under the influence of adrenal and gonadal steroid hormones. During the reproductive years, the vagina responds to ovarian steroid hormone cycling, and both tissues adapt to the needs of pregnancy and delivery. Following menopause, the vulva and vagina atrophy. A rise in the prevalence of incontinence among older women increases the risk of vulvar and perineal dermatitis. This chapter covers the morphology and physiology of the genital area from infancy to old age.

Products used on female genital mucosa.

A wide variety of products are used by women in the genital area and, therefore, come into contact with the genital mucosa. The largest category of such products would be those used for cleanliness and odor control, such as soaps and body washes, douches, premoistened wipes and towelettes, dusting powder and deodorant sprays. A second large category of products are those intended to absorb fluids, such as products used for menstrual protection (tampons, pads and panty liners) and incontinence protection. Lubricants and moisturizers, and aesthetic products (hair removal products and dyes) are also fairly common. In addition, over the counter medications are now available for the treatment of fungal infections. This chapter briefly discusses the products women use on or around the genital area, the perceived or real benefits, and the potential health effects of these products.