Cosmeceutical trial analysis
DMP provide the analysis for regular cosmeceutical trials conducted by a UK-based trials unit – the end clients for these trials being many well-known cosmetics & pharmaceutical companies. The analyses provided ultimately display a product’s effectiveness or innocuousness.
Customers typically seek analyses that answer the following:
- Is my new product effective in producing effect A?
- Does my product produce its claimed benefits?
- Is our potential replacement for an existing product similarly innocuous in terms of skin irritation?
- Which of several competing products is most effective?
The data are the result of human trials, where dryness, redness, irritation, hydration are quantified under differing product applications. Perceptions of effects may also be recorded. The data typically represent measurements over multiple body locations, taken repeatedly on many subjects over several hours or days.
The studies are repeated measurements taken on subjects through time, which require classes of models that correctly account for this. Naïve treatment will almost certainly give incorrect conclusions. For example, giving incorrect conclusions about whether the products are significantly different from one another, or effective, or innocuous – i.e. the study will be wasted. DMP correctly account for this by using:
- Generalized Estimating Equations
- Generalized Mixed Models (linear, non-linear or smoother based)
The data are not necessarily continuous measurements of well-known magnitude e.g. high, medium or low. Data of this type must also be treated carefully to ensure valid results. DMP use Generalized methods to account for this common categorical-ordinal data type – specifically multinomial models.
DMP provide comprehensive reports with analysis results and method details. The practical consequences of the analyses are given in plain language as well as the supporting technical outputs.
The analysis outputs give clear evidence about the performance claims of cosmeceutical products. The results are defensible and may provide clients with strong statements for use in product advertising. For example:
Product A gives 10-20% greater hydration than competitor product B.
After only 2 hours, product A gives significantly greater hydration than product B
The data types from cosmeceutical studies are deceptively difficult and frequently analysed incorrectly. The repeated measurements on subjects and categorical-ordinal nature of the data will give rise to incorrect conclusions if treated naively. In short, we treat cosmeceutical trials with the same rigour required of regulated clinical trials.
DMP have the latest accepted methods for the analysis of cosmeceutical data – methods that conform to that required of true pharmaceuticals. Notably there are calls for cosmeceuticals to be bound by pharmaceutical-like regulations, given their claims of pharmaceutical-like properties. DMP are also researchers in statistics methods, so can produce novel method development for difficult cases.