Research in Cosmetic Dermatology: Reconciling medicine with business: (Part II / IV)
The term research has a different meaning in cosmeceutical industry. Some big organisations use the term for product or service improvement. Optimization of existing technology for specific needs (not necessarily different indications) is a common practice in cosmeceutical industry. Each organization conducts its on research for optimizing the technology. As this is often conducted without a proper understanding of clinical research paradigms, certain errors of judgment are frequently encountered.
THE NEED TO COMPARE
It is always worthwhile to compare new technologies to already available ones in terms of efficacy and adverse effects. For example several depigmenting agents are known with varying levels of efficacy. When a new and more expensive product combination is introduced, it is important to compare it with individual components used alone to justify the cost of the combination. However the decision of whether to adopt a new technology should not be based entirely on the results of comparison. But the comparison will give clear indications about the likely success and the potential problems during introduction and has substantial marketing value.
THE NEED TO RANDOMIZE
Randomization is given due importance in pharma trials. But many cosmeceutical researchers rely on a ‘study group cohort ‘rather than random sample. The active ingredient, vehicle or even contaminants in a cosmeceutical can cause an allergic or irritant reaction in a small percentage of users.(8) Manufacturers try to assess the risk during the trial period. If the trials are conducted on the same group always, the group undergoes a natural selection process as those who develop a reaction are unlikely to report for further trials. The results on this ‘thick skinned’ cohort cannot be reliably extended to the general population.
THE NEED FOR BLINDING
Blinding is another important concept often ignored in cosmeceutical research. Sometimes blinding can be difficult or impossible to implement especially for those trials involving machines. Hence most of the studies are plagued by researcher as well as subject bias. This bias gets confounded several times when the researchers also become part of the study group, a practice common in cosmeceutical research. Individual service providers often comment that they have tried the product or service on themselves and found it to be safe and effective. Having an independent blinded observer who does majority of assessment can significantly reduce the bias. But bias cannot be completely removed from study design in cosmeseutical research and should be kept in mind during final evaluation.
THE NEED FOR OBJECTIVE ASSESSMENT
The assessment is often subjective in cosmeceutical research. The unavoidable biases along with subjective assessment methods make the studies less credible. It is important to make full use of new, objective assessment techniques involving computer assisted image analysis and optical spectroscopy. Computer assisted image analysis is the computational extraction of meaningful information from digital images by pattern recognition and digital geometry.(9) Optical spectroscopy involves study of scattering and reflectance pattern of the skin for an objective assessment of appearance. (10)
THE NEED TO USE MOLECULAR AND CELL BIOLOGY TECHNIQUES
The chance of success for a cosmeceutical is likely to be higher if it has a strong basis in molecular and cell biology. Ingredients developed on the basis of its effect on well characterized molecular targets are more likely to be successful. The new generation growth factors and aquaporin modulators are typical examples.(11) The recent developments like in vitro human skin helps in assessing the efficacy and adverse effects of cosmeceuticals in a more objective and safe way.(12)
THE NEED TO CONSIDER SKIN AND LIFE-STYLE VARIATIONS
The importance of skin type in the choice of cosmeceuticals is well known. Certain lasers are considered not safe on darker skin as the chances of developing adverse effects are more.(13) The environment and life style can also have a significant effect on skin biophysical characteristics. Hence it is important to account for these confounding factors in study designs especially for those cosmeceuticals promoted as suitable for all skin types.
THE NEED FOR LONG TERM FOLLOW-UP
Since cosmeceuticals are not strictly regulated, products are introduced based on studies conducted for a few days or weeks or at most a few months. Since a watchdog like FDA is not present, certain technologies are introduced into the market without enough studies to back the safety claims of manufacturers. Often the user is not even aware of this fact. Permanent dermal fillers are a typical example.(14) It is known that foreign bodies can elicit a tissue reaction after prolonged periods of exposure. Hence short term safety of dermal fillers does not guarantee its long term safety after several injections. Long term follow-up studies are lacking for many dermal filler materials. The same applies to other techniques like laser as well.