Publishing the nuisance negative study

Abstract

The clinical research study has become the standard test for efficacy validation of both prescription and over-the-counter dermatologics. The typical design is a double-blind, placebo-controlled study. In pharmaceutical trials, there can be no doubt that the placebo-controlled trial is the ideal study model. One group of subjects receives the actual medication, whereas the other balanced group of subjects receives a sugar pill. The study for oral medications is clear-cut; however, this is not the case for studies of topical medications or cosmeceuticals, which form the majority of the research published in the Journal of Cosmetic Dermatology In many cosmeceutical formulations, the main active is the vehicle, not the novel ingredient complex. Although it would be important to study the novel cosmeceutical in the vehicle and the vehicle alone as the two study arms, the vehicle effect may be so profound as to make it impossible to achieve statistical significance. A combination of petrolatum, glycerin, and dimethicone in the cosmeceutical vehicle has profound cutaneous effects to include the reduction of transepidermal water loss, enhanced skin hydration, improved tactile smoothness, increased skin shine, reduced pruritus, and minimized wrinkles. These effects are so dramatic that vehicle cannot be classified as inactive. Yet, a novel cosmeceutical ingredient must provide some added benefit to the formulation beyond the moisturizing vehicle. Perhaps then, cosmeceutical studies should be designed as the novel cosmeceutical ingredient in the vehicle compared with no treatment. This too would be a faulty study design. Even the poorest functioning moisturizer is better than nothing at all. A cosmeceutical study must include a comparative product, but the choice of the comparative product can yield an artificially positive or negative study. Many studies will test a new formulation against the current market leader. This design is not valuable for medical purposes. I believe that topical cosmeceuticals should be studied with the same attention to scientific detail as topical pharmaceuticals. This may mean that the study results comparing the active plus the vehicle to the vehicle alone may be negative, but publishing a well-designed and well-executed negative study may be just as important as publishing a positive study. If a drug does not demonstrate efficacy in phase III clinical testing, it will not receive Food and Drug Administration approval, and the practicing physician will never see the medication in the marketplace. On the other hand, many cosmeceuticals containing ingredients with no efficacy data are sold on a daily basis. It is for this reason that negative cosmeceutical studies are extremely valuable and should be published. One of the problems with publishing negative cosmeceutical studies is the right of the sponsor to withdraw support and prohibit publication. This is unfortunate. Negative studies should guide ingredient and product manufacturers. Whereas a negative study may prevent a product launch, it also may prevent a product failure and in the end save a corporate reputation. The consumer will ultimately determine whether a cosmeceutical works based on repeat product purchase. Products that do not work are ultimately destined to fail. Although the negative study may initially seem to be a nuisance, in the end, valuable insights may be obtained.