Correlating Sensory Effects With Irritation

Abstract

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.

Sensitive skin: new findings yield new insights

“…Some individuals possess exaggerated sensitivity to specific individual irritants (37). Despite the fact, however, that studies have demonstrated that sensitiveskin patients are capable of distinguishing products on the basis of blinded sensory endpoints (18,33), a clinically satisfactory description of observed sensitivities remains out of reach.…”

“…Most methods focused on objective assessment of physical effects to skin rather than the sensory effects reported (33), and few reports have quantified sensory effects or correlate sensory effects to degree of irritation. Most testing has included few subjects, and few have restricted subjects to those with demonstrated sensitivity (34).…”

Cumulative Skin Irritation Test of Sanitary Pads in Sensitive Skin and Normal Skin Population

“…Ideally, testing in this population should be able to correlate participants' subjective cutaneous symptoms with objective data (3,11). Such testing methods should also be minimally invasive, reproducible, and cost-effective (12).…”

Assessing the Dermal Safety of Products Intended for Genital Mucosal Exposure

“…Nevertheless, consumers develop product preferences on the basis of perceived skin effects that are not always predictable based on results of the skin effect testing programs such as the ones described above. Sensory data collected from panelists participating in skin effect testing indicate that panelists can sometimes discriminate between products on the basis of how they feel during use, even when clinically evaluated skin effects (erythema and dryness) show no differences [36][37][38]. Additionally, an important subgroup of consumers for products intended for the genital area is constituted by the elderly.…”

“…Sensory data are collected using simple questionnaires to determine the frequency of unpleasant sensations such as dryness, burning and itching. We have incorporated measures of sensory effects in clinical studies on feminine hygiene pads and wipes [33,45,46], nasal irritation studies [37] and BTK studies [36].…”