ABSTRACT

Investigating cutaneous effects is a fundamental step in assessing the safety of topical products. The arsenal for evaluating cutaneous effects includes standardized predictive skin patch tests such as single-and multiple-exposure patch tests for irritation and repeat insult patch tests for contact sensitization. However, standard patch test methodologies, which were designed to assess the skin at exposed or partially occluded areas of the anatomy, may not be ideally suited to assessing topical reactions in specialized epithelia, such as the vulva. The vulva differs substantively from skin at other sites in morphology and regional differentiation,1 tissue structure,2,3 blood fl ow,4 occlusion,5 and tissue hydration,5,6 which may in turn infl uence its susceptibility to topically applied agents.7-10 This review compares the characteristics of vulvar epithelia to skin at other sites (Table 82.1) and describes research aimed at adapting and developing cutaneous test methods to assess topical vulvar exposures.