Evaluation of a quantitative clinical method for assessment of sensory skin irritation.

Sensory skin irritation refers to the myriad of symptomatic complaints (e.g., sting and burn) frequently associated with inflammatory skin conditions or skin intolerance to various chemicals or finished products. Sensory irritation is an important factor in consumer acceptance of the products that they buy and use; however, from a safety testing and risk assessment standpoint, it has been difficult to evaluate. Recently, methods have been developed to more quantitatively assess sensory irritation using a semantically-labeled scale of sensation intensity, the labeled magnitude (LM) scale. Using this device, studies were conducted to determine if test subjects' perceptions of recalled or imagined sensory responses (from a series of survey questions) were related to their actual sensory reactivity to chemical challenge. Subjects were presented with 15 skin sensation scenarios of varying intensities and asked to record their self-perceived recalled or imagined responses using the LM scale. Individual and mean responses to each of the 15 survey questions were compared within and across studies. Considerable variation was seen between subjects' responses to the questions, particularly for questions pertaining to stronger stimuli (e.g., scalding water or skin lacerations). There was also little consistency seen in the pattern of individual responses across the questions. However, among 4 different study populations, the group mean scores for each of the 15 survey questions showed a high degree of consistency. Also, in spite of the variability in perceived responses to the recalled/imagined skin sensations, statistically significant dose-response and time-response patterns were observed in chemical (lactic acid and capsaicin) challenge studies. In one capsaicin study, a direct relationship was observed, among 83% of the study subjects, between the mean recall intensity scores and actual responses to subsequent capsaicin challenge. This pattern was not seen in a lactic acid challenge study. However, a similar relationship was seen in this study if only recall stimuli related to sting-type responses were included in the analysis. Hence, use of recall/imagined skin sensation perception data for prediction of actual reactivity to chemical probes may have screening utility depending on the survey questions used. On the whole, the LM scale is of practical use for quantifying subjective sensory irritation responses. Combined with evolving noninvasive instrumental and bioassay procedures for identifying biophysical or inflammatory markers of sensory irritation, better methods are on the horizon for improving our sensory skin irritation testing and risk assessment capabilities.

RCT Entities:   Population Interventions Outcomes