ABSTRACT
Investigating cutaneous effects is a fundamental step in assessing the safety of topical products. The conventional arsenal for evaluating cutaneous effects includes single-and multiple-exposure patch tests for skin irritation as well as repeat insult patch tests for contact sensitization. However, these standard patch test methodologies, which were designed to assess skin effects at exposed or partially occluded areas of the anatomy, are not optimized for evaluating topical reactions in specialized epithelia, such as the vulva. The vulva differs 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), factors which may in turn infl uence its susceptibility to topically applied agents (7-10). Moreover, certain subpopulations, such as older women, may be more susceptible to vulvar injury due to postmenopausal vulvar atrophy and the increased prevalence of urinary incontinence (11,12); indeed, genital skin sensitivity is more likely to be reported by 50 years or older people (13,14). This review compares the characteristics of vulvar epithelia to skin at other sites (Table 54.1) and describes how cutaneous test methods are being adapted to better assess the potential effects on vulvar tissue.
