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Miranda A Farage

Publications and source records attributed to Miranda A Farage.

14 recordsLinked to original sources
PubMed2006

Cutaneous and sensory effects of feminine hygiene pads among women with recent genital infection.

We compared the skin compatibility of two menstrual pad technologies in a single-center, parallel, randomized, examiner-blinded study involving adult women. This report presents the results of a subset of 10 participants who had a genital infection within 12 months prior to the start of the study. In a blinded fashion, participants were randomized to receive one of the two pads for use over two menstrual periods. Participants' skin erythema was graded 24-48 hours following cessation of menstrual flow and on day 14 of each menstrual cycle. Participants subjectively reported any sensory effects. Vulvar erythema scores for the mons pubis, labia majora, labia minora, perineum, buttocks, left medial thigh, and right medial thigh assessed after both menstrual cycles were not statistically different between groups or between the two different products. A low incidence of itching and burning occurred in both groups without statistical significance; none of the participants experienced a recurrent or new genital infection. These preliminary results show that participants with recent genital infections included in clinical studies do not exhibit greater vulvar erythema or sensory effects than participants without recent genital infection. The study showed that the safety profile of the products tested remained acceptable in women with recent genital infection.

Adult↗
PubMed2006

An investigator-blind, single-center, controlled, parallel group study to confirm the suitability of sanitary pads for menstrual protection in an ethnic nigerian population.

This study assessed the suitability of a widely used brand of sanitary pad with a formed film top sheet (study pad) for comfort, protection from soiling, and fit to underwear in a local female Nigerian population compared to a leading nonwoven product (reference pad) marketed in Nigeria. Two hundred eighty-nine healthy Nigerian women 18-45 years of age were randomized to wear one of the brands over two menstrual cycles. Both groups reported comparable (yet few) sensations of itching, rubbing/chafing, redness/rash, and burning/stinging. Participants rated menstrual protection of the study pad statistically significantly better for 88% of questions on a rating form. The percentage of negative comments regarding leakage and pad slip was statistically significantly lower for the study pad than for the reference product. There were no pad-related adverse events. These results show that the study pad was preferred in terms of comfort, protection from soiling, and fit to underwear. Further, top sheet technologies do not differ from nonwoven products in terms of compatibility to skin during use.

Adolescent↗
PubMed2006

Sensory, clinical and physiological factors in sensitive skin: a review.

Certain individuals experience more intense and frequent adverse sensory effects than the normal population after topical use of personal care products, a phenomenon known in popular usage as sensitive skin. Consumer reports of sensitive skin are self-diagnosed and often not verifiable by objective signs of physical irritation. Companies who manufacture cosmetic and personal care products are challenged to provide safe products to an audience with tremendous differences in skin type, culture and habits. This review examines the still incomplete understanding of this phenomenon with respect to aetiology, diagnosis, appropriate testing methods, possible contributing host factors such as, sex, ethnicity, age, anatomical site, cultural and environmental factors, and the future directions needed for research.

Age Factors↗
PubMed2006

The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation.

BACKGROUND/PURPOSE: The 'Behind-the-Knee' method (BTK test), using the popliteal fossa as a test site, evaluates both the inherent chemical irritation, and the potential for mechanical irritation of substrates and products. This approach eliminates some of the difficulties of in-use clinical test systems while still providing reliable results. In this publication, examples of the results of BTK tests on several materials are presented with direct comparisons, where possible, with results of in-use clinical testing conducted on the same materials. METHODS: In in-use clinical tests, volunteer panelists were provided with catamenial products to use in place of their normal product. In the BTK test, samples were applied daily to the popliteal fossa using an elastic athletic band. In both studies, irritation reactions were scored visually. RESULTS: Levels of irritation in the BTK test are consistently higher than those of standard patch tests, illustrating the contribution of mechanical irritation to the overall irritant potential of materials and products. Repeated tests on identical test materials demonstrated that the BTK test results are reproducible. Side-by-side comparisons of the BTK test and in-use clinical tests demonstrated that the BTK test produces results of similar quality to the in-use clinical. By using several concurrent panels with a common test material, it is possible to compare the irritant properties of several materials at once. CONCLUSIONS: We have tested over 25 different materials in over 35 BTK studies. The test method has proven reliable and versatile in testing a wide variety of materials, including menstrual pads, topsheets, interlabial pads, pantiliners, tampons and lotion coatings on products. Unlike in-use clinicals, the BTK test allows the direct comparison of two products at one time on the same individual, and is easily adapted to investigative programs. It is subject to fewer confounding factors, is much easier to implement, has a shorter turnaround time, and is less expensive than in-use clinical testing. Importantly, unlike standard patch tests, the BTK test evaluates both the inherent chemical irritation associated with materials and the mechanical irritation owing to friction. Although the BTK test was developed using catamenial products, the test system provides a valuable alternative for evaluating any material where mechanical irritation may play a role, including textiles, facial tissues, baby and adult diapers, and laundry products that may leave residues on fabrics.

Absorbent Pads↗
PubMed2005

Vulvar vestibulitis syndrome: a review.

Vulvar vestibulitis syndrome (VVS) is a perplexing disease involving pain limited to the vulvar vestibule without objective clinical findings to explain the symptoms. The condition impairs sexual function and creates significant psychological distress. Its cause is unknown, and few randomized studies exist on the efficacy of interventions. This article reviews disease characteristics, possible etiologies, and approaches to management.

Dyspareunia↗
PubMed2005

Vulvar susceptibility to contact irritants and allergens: a review.

Vulvar tissue differs from cutaneous epithelia in structure, morphology and biophysical characteristics. For example, the skin of the labia majora exhibits elevated hydration, occlusion and frictional properties, which may increase susceptibility to irritants and contact sensitizers. Furthermore, the nonkeratinized vulvar vestibule is likely to be more permeable than keratinized regions. These differences heighten vulvar susceptibility to topical agents. This reviews the structure and properties of vulvar tissue, emphasizing their impact on susceptibility contact irritants and allergens.

Allergens↗
PubMed2005

Correlating sensory effects with irritation.

The goal of this preliminary study was to examine data collected in the course of the development and conduct of the behind-the-knee (BTK) test for correlations between the objective scores of erythema and the sensory effects reported by the panelists. In addition, the intensity of physical characteristics of femcare products and prototypes was evaluated using the descriptive analysis panel (DAP) and results were compared to the BTK results to determine if certain physical characteristics of the products correlated to different sensations experienced by the BTK panelists. Test materials were commercially available or developmental catemenial products. In the BTK test, samples were applied daily to the area behind the knee and held in place for 6 hours per day for 5 consecutive days by an elastic knee band of the appropriate size. Irritation was graded 30-60 minutes after removal of each application. The DAP uses individuals trained to recognize and grade certain physical characteristics of products, including degree of plastic feel, scratchiness, glide, and cottony feel. In the BTK studies, the ability to differentiate between the test samples via reported sensory effects correlated with the ability to differentiate via objective scores for irritation in seven of 15 comparisons. A correlation between the magnitude of the irritation score, independent of the specific test sample, and reports of adverse sensory effects was observed in 13 of 15 comparisons. Two comparisons conducted in the BTK were also evaluated using the DAP. For one comparison, there was a clear difference in the product physical characteristics in the DAP that was consistent with mean erythema scores and reported sensory effects in the BTK. For the other comparison, there was no clear difference between the two products by either the DAP or the BTK.

Journal Article↗
PubMed2005

Assessing the skin irritation potential of facial tissues.

UNLABELLED: Our primary objective was to develop a short-term test system for evaluating differences in the irritant effects of facial tissues that could be used as a screening tool for product improvements with regard to skin mildness. The strongest evidence for product superiority is based on a combination of data: 1) subjective (i.e., panelist or consumer preference with regard to the attributes important to skin effects) and 2) expert clinical evaluation (i.e., a quantitative measure of product superiority by a third party, such as erythema and dryness scores). In this assay, both measures were evaluated. METHODS: In three separate studies, facial tissue products were compared with a currently marketed product with a lotion coating (product A). Test materials included products B and C (each without a lotion coating) and product G (a facial tissue product coated with a developmental lotion). Panelists (15-16 per study) were assigned one tissue product to use on one side of the nose and the other product on the alternate side. They were asked to wipe the tissue from the nasal bridge to the upper lip for 10 wipes every 20 minutes for a total of 170 wipes (17 series) daily on Monday through Thursday. Prior to the first test product application, the integrity of the skin on the nasolabial folds was compromised by tape stripping using successive applications of occlusive tape. Erythema and dryness were scored by a trained grader every morning and afternoon. Panelists were asked specific questions about product preference at the end of each day. RESULTS: Based on the statistical analysis, the reported sensory effects were the most reliable measure of product differences, with panelists showing a clear preference for the lotioned product (A) over the nonlotioned products (B and C), and slight preference for product A over the other lotioned product (G). The clinical evaluation measures of irritation (erythema and dryness) were less consistent in detecting product differences. Those differences that were detected were generally consistent with the sensory effects data. CONCLUSIONS: This assay detects significant panelists' preferences and, therefore, forms a useful part of the arsenal for evaluating skin effects and claims support. However, without further modification, the assay is not sufficiently robust to reliably detect differences in the clinical measures of irritant effects (erythema and dryness).

Journal Article↗
PubMed2005

Are we reaching the limits or our ability to detect skin effects with our current testing and measuring methods for consumer products?

Testing for potential adverse skin effects is a key part of both the overall safety assessment for many consumer products and the evaluation of potential product improvements in mildness. Whilst modern tissue and paper products (i.e. facial tissues, catamenial products, baby wipes and baby and adult diapers) are inherently very mild to skin, current test methodology may not be robust enough to evaluate future improvements in such products. This article provides a commentary on several technologies we have been exploring to improve the sensitivity of test methods for tissue and paper products. The focus has been on three approaches: (i) further exaggerating exposure conditions using novel approaches to sample application, (ii) increasing the sensitivity of the manner in which we score for irritant effects, either visually or via instrumentation and (iii) quantitatively measuring additional endpoints, i.e. subjective sensory effects.

Consumer Product Safety↗
PubMed2004

Evaluation of modifications of the traditional patch test in assessing the chemical irritation potential of feminine hygiene products.

BACKGROUND/AIMS: The first main objective of the work presented in this paper was to investigate ways of optimizing the current arm patch test protocol by (1) increasing the sensitivity of the test in order to evaluate more effectively the products that are inherently non-irritating, and/or (2) reducing the costs of these types of studies by shortening the protocol. The second main objective was to use the results of these studies and the results of the parallel studies conducted using the behind-the-knee method to better understand the contribution of mechanical irritation to the skin effects produced by these types of products. In addition, we were interested in continuing the evaluation of sensory effects and their relationship to objective measures of irritation. METHODS: Test materials were prepared from three, currently marketed feminine protection pads. Wet and dry samples were applied to the upper arm using the standard 24-h patch test. Applications were repeated daily for 4 consecutive days. The test sites were scored for irritation prior to the first patch application, and 30-60 min after removal of each patch. Some test sites were treated by tape stripping the skin prior to the initial patch application. In addition, in one experiment, panelists were asked to keep a daily diary describing any sensory skin effects they noticed at each test site. RESULTS: All protocol variations ([intact skin/dry samples], [compromised skin/dry samples], [intact skin/wet samples], and [compromised skin/wet samples]) gave similar results for the products tested. When compared to the behind-the-knee test method, the standard upper arm patch test gave consistently lower levels of irritation when the test sites were scored shortly after patch removal, even though the sample application was longer (24 vs. 6 h) in the standard patch test. The higher level of irritation in the behind-the-knee method was likely due to mechanical irritation. The sensory skin effects did not appear to be related to a particular test product or a particular protocol variation. However, the mean irritation scores at those sites where a sensory effect was reported were higher than the mean irritation scores at those sites were no sensory effects were reported. CONCLUSIONS: All four protocol variations of the standard upper arm patch test can be used to assess the inherent chemical irritant properties of feminine protection products. For these products, which are inherently non-irritating, tape stripping and/or applying wet samples does not increase the sensitivity of the patch test method. Differences in irritation potential were apparent after one to three 24-h applications. Therefore, the standard patch test protocol can be shortened to three applications without compromising our ability to detect differences in the chemical irritation produced by the test materials. The patch test can be used to evaluate effectively the inherent chemical irritation potential of these types of products. However, this method is not suitable for testing the mechanical irritation due to friction that occurs during product use. There is no relationship between specific test conditions, i.e., compromised skin and/or testing wet samples and reports of perceived sensory reactions. However, there seems to be a clear relationship between sensory reactions and objective irritation scores.

Absorbent Pads↗
PubMed2004

Development of a sensitive test method to evaluate mechanical irritation potential on mucosal skin.

BACKGROUND/PURPOSE: The studies presented here are intended to continue the validation of the behind-the-knee test system developed to evaluate the mechanical irritation potential of products such as catemenial pads, baby and adult diapers (which are inherently non-irritating products/chemicals). These products are intended to be worn for prolonged periods of time on body sites that include the mucous membrane and non-keratinized epithelium in addition to normal squamous cell epithelium. These studies had two specific goals. The first was to validate the test model using a variety of conditions, including those that mimic the conditions that exist during normal product use. The second specific goal was to determine the most cost-effective protocol to use for screening different product executions for potential irritant effects. If the model proves to be reliable under a variety of conditions, it will be an ideal test system to use in claims support studies, where it is preferable to mimic use conditions as closely as possible. We were also interested in evaluating sensory responses that consumers often associate with irritation to determine if any of these sensations correlated with objective measures of irritation. METHODS: Three test materials were used in these experiments. All three are commercially available catemenial pads that were expected to be similar, but not identical, in irritant properties based on subjective consumer reports of irritation associated with product use. Test materials were applied daily to the area behind the knee and held in place for 6 h by an elastic knee band of appropriate size. Irritation was graded 30-60 min after test product removal, and the following morning before application of the next sample. Two products were compared using four different protocol variations: dry product on intact skin, dry product on tape stripped (compromised) skin, wet product (i.e., product loaded with 8 mL of saline) on intact skin and wet product on compromised skin. An additional study compared the two products using two protocol variations (intact skin/dry product vs. compromised skin/wet product). In addition, a study (#5) was conducted to compare a third product applied wet on intact vs. compromised skin. In the final two studies, information was collected from the panelists on subjective sensations of irritation. RESULTS: All four protocol variations were capable of detecting significant differences between the products. These differences were directionally similar to what was expected based on subjective consumer comments. In addition, a higher number of certain perceived sensory effects were reported for the more irritating product. CONCLUSIONS: In these studies, Product A is more irritating than Product B when assessed objectively, i.e., by scoring irritation at the test sites, and subjectively, i.e., by evaluating reports of adverse sensations perceived by panelists. There is no clear relationship between specific test conditions, i.e., compromised skin and/or testing wet samples, and reports of perceived sensory reactions. However, some sensory reactions appear to be associated with higher levels of irritation. The most cost-effective protocol to use for screening for potential irritant effects for catemenial pads, baby and adult diapers is two 6-h sample applications on intact skin, with scoring in the afternoon 30 min after removal of the sample. For claims support testing, a variety of test conditions can be used in the behind-the-knee assay to mimic the exposure conditions for the product under evaluation, including using compromised (tape stripped) skin and wet product samples.

Absorbent Pads↗
PubMed2003

Quantitative risk assessment for the induction of allergic contact dermatitis: uncertainty factors for mucosal exposures.

The quantitative risk assessment (QRA) paradigm has been extended to evaluating the risk of induction of allergic contact dermatitis from consumer products. Sensitization QRA compares product-related, topical exposures to a safe benchmark, the sensitization reference dose. The latter is based on an experimentally or clinically determined 'no observable adverse effect level' (NOAEL) and further refined by incorporating 'sensitization uncertainty factors' (SUFs) that address variables not adequately reflected in the data from which the threshold NOAEL was derived. A critical area of uncertainty for the risk assessment of oral care or feminine hygiene products is the extrapolation from skin to mucosal exposures. Most sensitization data are derived from skin contact, but the permeability of vulvovaginal and oral mucosae is greater than that of keratinized skin. Consequently, the QRA for some personal products that are exposed to mucosal tissue may require the use of more conservative SUFs. This article reviews the scientific basis for SUFs applied to topical exposure to vulvovaginal and oral mucosae. We propose a 20-fold range in the default uncertainty factor used in the contact sensitization QRA when extrapolating from data derived from the skin to situations involving exposure to non-keratinized mucosal tissue.

Allergens↗