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.

Support of adult urinary incontinence products: recommendations to assure safety and regulatory compliance through application of a risk assessment framework.

Urinary incontinence (UI) or involuntary loss of urine is a common chronic medical condition among women. It is estimated that 5%-70% of the population experiences incontinence with most studies suggesting 25%-45% of the population. Varying definitions of UI (e.g., stress, urgency, mixed) exist, and inconsistent symptom assessment tools, age, and gender can affect the estimate of incidence. Disposable Adult Incontinence products were first introduced into the market in the late 1970s and initially were used mostly in nursing homes and hospitals. However, during the 1980s, the market for incontinence products via retail outlets dramatically increased as awareness of the benefits of the products grew and stigma about their use declined. Today's products that manage urine loss have an extensive history and have evolved with time. Always products were introduced into the market in 2014 and are designed to meet the needs of women of all ages. Considered medical devices in some countries, regional regulations and global guidelines require clear planning, thorough assessment, and concise documentation of clinical safety. This manuscript will briefly review the regulatory landscape with a specific focus on European Union regulations. As previously published, the iterative, risk assessment framework used to assess the safety of Always incontinence products confirms that these products are compatible with skin and can be used safely. This manuscript will expand on the current literature highlighting additional steps that help assure the safety and compliance of the products from quality assurance programs through comprehensive post-market safety surveillance. Recommendations to help ensure several of the key regulatory requirements are met are outlined in the context of a risk assessment framework used to assure safety.

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.