"Cosmeceuticals"—a fusion of the terms "cosmetic" and "pharmaceutical"—represent one of the most promising, yet challenging treatment options available to physicians. Cosmeceuticals (or

alternatively, cosmaceuticals) are topical cosmeticpharmaceutical hybrids intended to enhance the beauty through ingredients that provide additional health-related function or benefit. They are applied topically as cosmetics, but contain ingredients that influence the skin's biological function.[1] The Food, Drug, and Cosmetic Act defines cosmetics by their intended use, as ‘articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.' These cosmeceuticals, serving as a bridge between personal care products and pharmaceuticals, have been developed specifically for their medicinal and cosmetic benefits.

CHEMICAL CONSTITUENTS

a) Anti-Inflammatory Agents

Salicylic acid

 Glycolic acid

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b) Depigmenting Agents

Arbutin

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c) Barrier Enhancing Agents

Ceramide

?Phosphatidylcholine

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d) Anti-Oxidants

 Vitamin C

?Vitamin E

?Plant phenols

?

Clinical trials evaluating cosmeceuticals agents.

Agent                Clinical indication              Study type          Patient               Results

Salicylic Acid              Acne                               DB, R                   30               16.6 to 10.9 comedones

                                   Acne                               DB, R                  180              68% of patients improved

Glycolic Acid              Acne                               DB, R                    70               45% of patients improved

                                   Acne                               DB, R                    40              90% of patients improved

                                  Photodamage                  DB, R                    74              76% of patients improved

                                  Discoloration                   DB, R                    75               76% of patients improved

                                  Stretch marks                  OL, Cl                   10               68% of patients improved

                                  Hyperpigmentation          DB, R                    65               25% of patients improved

                                  Melasma                         DB, R                     39               75% of patients improved

                                  Atopic blepharitis            DB, R                     8                 10.6% more hydrated

 Ascorbic acid           Hyperpigmentation          DB, R                    16                62% of patients improved

                                 Wrinkling,                         DB, R                    10               40% of patients improved

                                 Wrinkling, photoaging      DB, R                    19               84% improvement

                                 Stretch marks                   OL, Cl                   10               48% improvement

Phosphatidylcholine Lower-lid bulging              OL, Cl                   30               100% of patients improved

Oligopeptide              Wrinkles, skin aging        OL, Cl                   90               80% reduction in wrinkles

Peptide Primers        Wrinkling                          OL, Cl                   14              57% of patients improved

TGF-â1                     Wrinkling                          DB, R                   32              87% of patients improved

Pal-KTTKS                Wrinkling                          DB, R                   49              37% less wrinkle volume

                                  fine lines                           OL, Cl                  92              13% length reduction

Retinaldehyde           Acne                                 OL, Cl                1,709           61% of patients improved

                                  Acne                                 DB, R                   87              86% of patients improved

Vitamin K                  Post-laser purpura            DB, R                   20              0 vs. 0.6 degrees of disclrtn

Abbreviations: DB: double blind; R: randomized; OL: open-label; CL: closed-label.

REGULATORY ASPECTS

The claims made about drugs are subject to high scrutiny by the Food and Drug Administration (FDA) review and approval process, but cosmetics are not subject to mandatory FDA review.

cosmeceuticals represent the fastest growth segment in the skin-care market, and a number of topical cosmeceutical treatments for conditions such as photoaging, hyperpigmentation and wrinkles have come into widespread use.[2, 3] In 2005, the U.S. cosmeceutical market was estimated to be $12.5 billion and projected to grow to over $16 billion by 2010. Demand for cosmeceutical products is expected to increase 8.5 percent per year to over $8 billion in 2010.