Get access

The vulvar epithelium differs from the skin: implications for cutaneous testing to address topical vulvar exposures

Authors

  • Miranda Farage,

    Corresponding author
    1. The Procter & Gamble Company, Feminine Care Research & Development, Cincinnati, OH, and
      Dr Miranda Farage
      The Procter & Gamble Company
      Winton Hill Business Center
      Box 136
      6110 Center Hill Road
      Cincinnati
      OH 45224
      USA
      Tel: +513 634 5594
      Fax: +513 634 7364
      e-mail: farage.m@pg.com
    Search for more papers by this author
  • Howard I. Maibach

    1. University of California School of Medicine, Dermatology Department, San Francisco, CA, USA
    Search for more papers by this author

Dr Miranda Farage
The Procter & Gamble Company
Winton Hill Business Center
Box 136
6110 Center Hill Road
Cincinnati
OH 45224
USA
Tel: +513 634 5594
Fax: +513 634 7364
e-mail: farage.m@pg.com

Abstract

Vulvar tissue is more permeable than exposed skin due to differences in structure, occlusion, hydration and susceptibility to friction. The safety assessment of products that contact the vulva should account for this potentially heightened permeability. Standard clinical patch tests may not sufficiently mimic vulvar exposures. Because testing on the vulva is not routinely feasible, we are investigating new and modified cutaneous test methods to increase the degree of conservatism of the safety assessment. To this end, we have 1) developed a method to assess chemical and frictional effects by means of repeated application to the popliteal fossa (the behind-the-knee test); 2) modified the quantitative risk assessment for the induction of allergic contact dermatitis; and 3) proposed a modified human repeat insult patch test for assessing materials intended for vulvar contact. Modification of the traditional 4-day, irritation patch test by using wet samples or compromized skin sites failed to enhance test sensitivity. Future studies will evaluate testing in subjects with heightened susceptibility to chemical and sensory irritation, in order to increase test sensitivity to chemical irritants. These approaches can be employed to augment the margin of safety when cutaneous test methods are applied to agents that contact the vulva.

Get access to the full text of this article

Ancillary