Cosmeceutical hype does not benefit our patients

January 1, 2008

A recent headline in Dermatology Times read, "Niacin boosts IPL outcome." In small print, the sub-headline read, "Small study sees non-statistical improvement in skin texture." The summary of the article, called "Quick Read," had the following statement: "A niacin-based skincare cosmeceutical regimen combined with intense pulsed light (IPL) treatments offers better skin rejuvenation outcomes than IPL alone, a new study suggests."

A recent headline in Dermatology Times read, "Niacin boosts IPL outcome." In small print, the sub-headline read, "Small study sees non-statistical improvement in skin texture." The summary of the article, called "Quick Read," had the following statement: "A niacin-based skincare cosmeceutical regimen combined with intense pulsed light (IPL) treatments offers better skin rejuvenation outcomes than IPL alone, a new study suggests."

The person who conducted the study was interviewed and commented that in spite of the apparently statistically negative data, "that was only part of the story." He noted "across-the-board improvements in the subjects using NIA 24 (the compound used in this protocol, which contains a derivative of niacin in a special vehicle delivery system) versus those using the placebo."

The product line was developed at our local university and was the subject of a recent glowing report by the hometown newspaper. The columnist crowed that this remarkable discovery has led to an agent that is now a major advance in the fight against skin aging.

Something has gone very wrong in the past several years. It appears that so-called "cosmeceuticals" are being held to an entirely different standard than other therapeutic agents prescribed or recommended by dermatologists and others.

I did a quick literature search, seeking published data which might support the efficacy of niacin and its derivatives for improvement of skin aging, the main indication for this product line. The best approximation of relevant data is from a study published in 2005 (Dermatol Surg. 31:860, 2005), which demonstrated an efficacy of niacinamide which was approximately one-third to one-fifth that of tretinoin.

I understand that NIA 24 may have an improved delivery system, which may make it a more effective product. However, until there are controlled clinical trials, perhaps with a direct comparison with tretinoin or other compounds in use today for this indication, how are we to conclude that this product will materially benefit our patients?

Call me jaded, but it is my view that a therapy such as this would never have enjoyed the commercial success that it has attained if physicians did not promote and sell this in their offices. I cannot picture a scenario in which significant numbers of dermatologists would advise patients to purchase a $100 product from a department store or from an Internet merchant unless there were substantial data that would support its use.

NIA 24 may turn out to be an excellent drug with many important uses, including skin cancer prevention and improvement of actinic damage. The results of future studies should sort this out. Until this documentation is available, why are we pushing this technology?

I have no specific axe to grind with regard to NIA 24. Rather, I am using it as an example of the way that we dermatologists and others are adding to the confusion about what is a proven, effective remedy and what is a cosmetic masking as a drug.

The whole concept of cosmeceuticals seems somewhat murky. We educate our patients that, by definition, cosmetics have no medical benefits at all. In what way does an agent with trivial benefits that cannot be distinguished from a placebo be differentiated from a cosmetic?

We owe it to our patients to help them sift through this marketing morass, and advise them based on our knowledge of the scientific method of experimentation and our understanding of the experimental data. Otherwise, we become no different than the health spa salesman selling products purely for profit.