Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Topical steroids are available as creams, lotions, gels and ointments; selection of an appropriate product can also provide good moisturization of the skin. The wide spectrum of potencies and bases allows these mediations to be used both effectively and safely while under the care of an experienced physician.
During flares, over-the-counter moisturizing preparations that include a topical corticosteroid (such as clobetasone butyrate and hydrocortisone) are helpful to control inflammation and restore the skin barrier. The intensive use of emollient-based products can reduce the need for topical steroids.
In summary, the three bioequivalence approaches that are currently consistently accepted by regulatory authorities are bioequivalence studies with clinical endpoints, in-vivo pharmacodynamic studies (in particular VCA for topical corticosteroid products), and waivers for topical solutions. Also, most require pharmacokinetic studies if there are safety concerns relating to systemic exposure. However, it is refreshing to see that the regulatory authorities are giving credence to alternative science-based methods for demonstration of bioequivalence, rather than insistence on clinical endpoint studies.