The complete article is available as a printable pdf file from the Munich Personal RePEc Archive (MPRA) below:
http://mpra.ub.uni-muenchen.de/16515/
Cosmetic dermatology is a unique specialty where clinical medicine has a legitimate but often detested relationship with business. There are people lined up on either side of the hazy line between medicine and business, each group trying to understand the other. True clinical dermatologists consider cosmetic dermatology an imprecise and vague specialty.(1)
A cosmeceutical, is conventionally defined as a cosmetic product claimed to have drug-like properties.(2) The term cosmeceutical is a portmanteau of the words “cosmetic” and “pharmaceutical” and is not recognized by Food and Drug Administration (FDA). A cosmeceutical is not subject to FDA review and approval processes.(3) Medical devices used in cosmetic dermatology range from cautery machines to lasers. Injectable enhancement products like Botox®(4) and dermal fillers are also popular. The Division of General, Restorative and Neurological Devices (DGRND) within FDA regulates most of the medical devices and injectable dermal fillers used by dermatologists.(5) In this article the term “cosmeceutical” is used to represent cosmetic products, injectable products and medical devices (like microdermabrasion and laser machines) used in cosmetic dermatology.
The pharmaceutical research paradigms of target identification, screening, lead optimization and clinical trials from phase I to IV do not directly apply in cosmeceutical research.(6) In pharma the industry decides what is good for the patient where as in cosmetic dermatology the patient decides what is good for him/her. Hence it is not imperative that a significant placebo effect be identified and accounted for even if it arises from a dominant bias. A typical example is Laser Hair Reduction. It is very difficult to conclusively prove that it is more effective than any other hair removal method to justify its cost. But it is a billion dollar industry and is considered a ‘successful technology’ in cosmeceutical arena.(7)
This article is an attempt to reconcile research in cosmetic dermatology with business and market research. First we discuss the basic requirements for clinical research in cosmetic dermatology. Then we move on to the uncertainties faced by decision makers and the mathematical models which may be of help in solving them. Finally we briefly discuss the market research techniques used in cosmeceutical industry.
To be continued..
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“Practical Aspects of Cosmetic Testing. How to Set up a Scientific Study in Skin Physiology” By
Joachim Fluhr