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Cosmeceuticals must be evaluated based on a variety of criteria. First, it is important to consider the location for product application. More moisturization is required around the eyes, for example, than around the nose. Second, the formulation can be adjusted to account for differential facial sebum production. Third, the value of the formulation can be assessed via noninvasive assessments, such as corneometry and transepidermal water loss. Photography may also be helpful in assessing facial appearance changes that are cumulative with use over time.

© 2021 S. Karger AG, Basel

The proper evaluation of cosmeceuticals is important to ensure optimal efficacy. It is sometimes hard to determine efficacy, since cosmeceuticals are basically cosmetics, which by definition are intended to adorn, scent, and color the skin. Since efficacy was never part of the role of cosmetics in skin care, no established guidelines exist for evaluating cosmeceuticals. Definite United States Food and Drug Administration (FDA) guidelines are in place for new drug approval, but the FDA at present has no jurisdiction over cosmetics, which are unregulated. There has been some conversation at the FDA about the regulation of new cosmetic ingredients utilizing the same approach presently in place for investigational new drug applications.

This chapter will focus on the evaluation of cosmeceuticals; however, the opinions expressed are those of the author. A cosmeceutical is basically a moisturizer with an added “hero” ingredient designed to discriminate the formulation from a traditional moisturizer, but lacking in clinical efficacy to the point where the product might be perceived by regulatory bodies as a drug. Most cosmeceuticals are applied to the face, which is the part of the body where photoaging is first observed. Thus, this chapter will focus on facial cosmeceuticals examining the needs of the face, moisturizer formulation, noninvasive testing, and clinical evaluation to establish efficacy.