A randomized, controlled trial comparing skin health effects and comfort of two adult incontinence protective underwear.

BACKGROUND/PURPOSE: It is important to confirm product use effects on skin health for products intended for prolonged skin contact. This study compared experimental and marketed reference adult incontinence protective underwear. METHODS: Randomized, single-blind (examiner), parallel study evaluating skin health effects in predominantly obese incontinent women normally using protective underwear (approximately 20% Type II Diabetes). Subjects wore experimental or marketed reference protective underwear daily, 14 consecutive days. Visual skin grading, transepidermal water loss (TEWL) assessed before, after 1 and 2 weeks of product wear. Overall assessment of comfort assessed. RESULTS: Of the 122 subjects (60 experimental and 62 marketed reference), 22 were diabetic and 88 were postmenopausal. Under the conditions of this study, there were no statistically significant differences in overall change from baseline for visual grading and TEWL between the experimental product and the marketed reference product for all subjects. Changes from baseline for skin erythema and skin marking were generally small for both products for all subjects as well as for both diabetics and non-diabetics. There were no serious adverse events (AEs), and no withdrawals due to AEs. Overall comfort assessments of size and fit were 'just right,' and skin comfort in the leg, waist and crotch areas were 'comfortable' or 'very comfortable' for both products. CONCLUSIONS: In-use 14-day testing demonstrated few statistical differences between experimental product with unique odor neutralizing technology and currently marketed product for skin assessments and comfort. Both products were comfortable and well-tolerated.

Skin benefits with a novel emollient-treated menstrual pad.

Manufacturers of consumer products consistently seek to improve marketed products in terms of both safety and efficacy. The desire for continued improvement is seen even in well-established products such as catamenial products which have existed in some form for thousands of years. A recent innovation in the design of menstrual pads is the addition of a surface finish of emollient for the purpose of increasing comfort during wear. The present paper presents different evaluations of such an emollient-treated menstrual pad with a novel absorbent core. These investigations demonstrated product tolerability, defined the optimal formulation and concentration of the emollient-containing finish, and demonstrated successful transfer of the emollient to the relevant skin surface. In addition, enhancement of skin moisturization, associated with exposure to the emollient-treated pad, was demonstrated by several technologies: assessment of skin moisturization by Corneometer®, skin friction testing, and skin capacitance.

How do perceptions of sensitive skin differ at different anatomical sites? An epidemiological study.

BACKGROUND: People with sensitive skin vary not only in the signs and symptoms they experience, but also in the degree of sensitivity at different anatomical sites. AIM: To determine patterns of perceived sensitive skin using an epidemiological approach among a general population, evaluating the results for ethnic, gender and age differences. METHODS: Questionnaires designed to evaluate perceptions of sensitive skin in general and at specific body sites (face, body and genital area) were given to 1039 people. Respondents were not selected based on any criteria related to sensitive skin, but consisted of people participating in other studies on consumer products. RESULTS: Of the study population, 68.4% claimed their skin was sensitive to some degree, 77.3% claimed sensitive facial skin, 60.7% claimed sensitive body skin and 56.3% claimed sensitive skin in the genital area. There were no significant gender, ethnic or age differences, except in the genital area; a higher percentage of women and African Americans claimed sensitive skin in this area. CONCLUSIONS: The prevalence of perceived sensitive skin was higher in this study than in previous reports. Individuals had different perceptions about the degree of sensitivity at different anatomical sites.

Intrinsic and extrinsic factors in skin ageing: a review.

As the proportion of the ageing population in industrialized countries continues to increase, the dermatological concerns of the aged grow in medical importance. Intrinsic structural changes occur as a natural consequence of ageing and are genetically determined. The rate of ageing is significantly different among different populations, as well as among different anatomical sites even within a single individual. The intrinsic rate of skin ageing in any individual can also be dramatically influenced by personal and environmental factors, particularly the amount of exposure to ultraviolet light. Photodamage, which considerably accelerates the visible ageing of skin, also greatly increases the risk of cutaneous neoplasms. As the population ages, dermatological focus must shift from ameliorating the cosmetic consequences of skin ageing to decreasing the genuine morbidity associated with problems of the ageing skin. A better understanding of both the intrinsic and extrinsic influences on the ageing of the skin, as well as distinguishing the retractable aspects of cutaneous ageing (primarily hormonal and lifestyle influences) from the irretractable (primarily intrinsic ageing), is crucial to this endeavour.

Evaluation of lotion formulations on irritation using the modified forearm-controlled application test method.

BACKGROUND/PURPOSE: Cold and allergy sufferers often develop irritation around the nostrils as a result of repeated and frequent rubbing of the skin site with facial tissues. This irritation is a combination of the inherent irritant properties of the tissue components (chemical irritation), and mechanical irritation from friction. Lotion-coated facial tissues are being developed to provide soothing, skin benefits, and to promote healing of this type of irritation. The objective of these studies was to evaluate the efficacy of different lotion formulations on facial tissues in preventing irritation, or aiding in the healing of irritation. METHODS: The modified forearm-controlled application test (Modified FCAT) was adapted as a means of quickly evaluating the relative skin benefits of various lotion formulations used to coat facial tissues. The test was conducted on the volar surface of the forearms of volunteer subjects. Test sites were pretreated with 24 h occlusive patches of sodium lauryl sulfate (SLS) to induce mild or moderate skin irritation. This was followed by repeated wiping of the lotion-coated tissues. Irritation was evaluated using visual scoring for erythema and dryness. Lotion formulation options were compared in the model. Comparisons included assessments of the type of fatty alcohol in the formulation (stearyl and cetearyl alcohol), the presence of silicone and the base formulation (mineral oil, petrolatum of a proprietary formula). RESULTS: Differences in the degree of erythema and dryness were detected among various formulation options. No differences were found between formulations containing stearyl or cetearyl alcohol. Low levels of silicone produced benefits in one of two experiments. The proprietary base formula produced greater reductions in erythema following treatment of SLS-irritated skin compared with mineral oil and petrolatum bases. CONCLUSIONS: The results indicated that this modification of the FCAT can be used to compare various lotion formulations for skin benefits and healing properties, and to rank qualitatively the benefits of various formulation options.

A noninvasive method to assess skin irritation and compromised skin conditions using simple tape adsorption of molecular markers of inflammation.

BACKGROUND/AIMS: We have developed a simple noninvasive method to assess inflammatory changes in human skin, even in the absence of visible clinical irritation. Our approach is based on a simple tape (Sebutape) adsorption method to recover molecular mediators of skin inflammation (e.g., cytokines). This procedure has been used to investigate baseline cytokine levels on skin, to assess normal skin condition and to evaluate changes due to chemical insult, existing dermatitis, or sun exposure. METHODS: In clinical studies, Sebutape was applied to normal appearing uncompromised skin, as well as to compromised (diaper or heat rash), chemically treated (sodium laurel sulfate), or sun-exposed skin. Sebutape was applied to the skin for a 1 min collection interval. Tapes were extracted in saline using a 10 min sonication, and the extracts were analyzed for human interleukin-1alpha (IL-1alpha), IL-1 receptor antagonist (IL-1RA) and IL-8 using commercial immunoassay test kits. The cytokine levels recovered from each tape extract were normalized to total protein (TP) levels. In infant product use tests, the severity of skin irritation (diaper and heat rash or erythema) was also assessed using a visual grading scale. RESULTS: The method itself caused minimal, if any, skin damage. Additionally, Sebutape was shown to quantitatively adsorb detectable levels of cytokine from normal-appearing (control) or compromised (e.g., rashed or chemically treated) skin. In infant studies, significant increases in IL-1alpha levels were found in skin exhibiting diaper rash, heat rash and erythema compared with normal appearing control skin sites. When these results were normalized to total protein levels recovered from each tape, the significance was maintained. A positive correlation (r2=0.82) existed between IL-1RA levels and diaper rash severity. Significant increases in IL-8 levels were recovered from diaper rash versus control skin sites. There were differences in baseline cytokine levels in normal skin related to body site and sun exposure. The IL-1 RA/IL-1alpha ratios for sun-exposed skin of the face and lower leg were significantly (P<0.05) higher (3-6-fold) than those for skin sites that typically receive minimal sun exposure (i.e., underarm, upper leg and upper back). There was a significant increase in IL-1alpha and a directional increase in IL-8 levels in adult skin sites treated with the irritant, sodium lauryl sulfate, even in the absence of visible skin irritation (erythema). CONCLUSION: Our results demonstrate that this method is a useful noninvasive technique for assessing skin inflammatory events. In addition, the method is simple and easily applied in a clinical setting, whether on infants or adults.

Development of a new test for mechanical irritation: behind the knee as a test site.

BACKGROUND/AIMS: Certain consumer products, such as feminine hygiene products, and baby and adult diapers, are worn for prolonged periods of time in close proximity to the skin. A sensitive test method was needed to evaluate these products and their components for the potential to cause mechanical irritation during use. METHODS: We investigated several test sites on the body where normal, daily activities provided the opportunity for movement and, therefore, friction. These test sites were: the back of the knee, the axilla, and the wrist. Three exposure regimens were tested: 6-h daily for 4 days, 24-h daily for 3 days, and 24-h daily for 4 days. Controls consisted of satin fabric (a non-irritating material) or burlap (an irritating material). Test materials were secured to the test sites using an Ace elastic bandage (on the back of the knee), a snug fitting garment (on the axilla), or an athletic band (on the wrist). Test sites were scored for irritation on a visual scale prior to the initial application and 30-60 min after removal each day. Data were evaluated for the ability to reliably detect irritating materials, and for the ability to consistently differentiate between irritating and non-irritating materials. Quantitative measures of these abilities were used to rank the overall effectiveness of various test protocols as a model for mechanical irritation. RESULTS/CONCLUSION: The results of these studies indicated that a protocol using the back of the knee as a test site with an exposure regimen of 6-h daily for 4 days, best met the success criteria for an effective test system for evaluating mechanical irritation.

Labial and vaginal microbiology: effects of extended panty liner use.

OBJECTIVE: The goals of this study were 1) to better define the labial microflora and 2) to evaluate whether extended non-menstrual use of panty liners would increase genital carriage of undesirable bacteria and predispose to infection. METHODS: Healthy female volunteers (224) were prospectively randomized into panty liner wear groups A (Always((R)) deodorant) and B (Always((R)) non-deodorant) and into a control group C (no panty liner wear) with instructions for non-menstrual +/- menstrual use >/=5 h daily for 6 months. Selected aerobic bacteria were semiquantitatively cultured from the inner labial groove, the posterior fornix of the vagina, and the cervix pre-study and post-study. Used panty liners were quantitatively cultured, and vaginal secretions were examined by gas chromatography for fatty acid ratios as a measure of microbial flora shifts. RESULTS: At the pre-study, labial microflora in this study population contained significantly higher frequencies of Staphylococcus, coliforms, other gram-negative rods, and enterococci, and a decreased frequency of Gardnerella vaginalis relative to the vaginal microflora. After 6 months use of panty liners the frequencies (and densities) of the selected microorganisms in these two sites had not changed compared to controls, and fatty acid analyses of vaginal secretions gave no evidence of shifts in the microbial flora. CONCLUSIONS: Frequencies of selected genital microflora were different for the labia compared to the vagina. No increased carriage of medically important species was detected for either site after 6 months of daily (average 7.8 h) panty liner use.