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Requirements for research in cosmetic dermatology

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part II / IV)

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/

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.

Research in Cosmetic Dermatology: Reconciling medicine with business: (Part I / IV)

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..

Notalgia Paresthetica

This patient presented to me with this pigmented itchy patch over the right infra scapular region. He had a neurological disorder with paresthesia extending to right finger tips. There is a report of successful treatment of this condition with Botulinum Toxin Type A. [Arch Dermatol. 2007; 143(8):980-982.]

Pitted keratolysis

Pitted keratolysis is caused by a cutaneous infection with Corynebacterium and Actinomyces. It is often associated with hyperhidrosis. It is common in this part of the world because of occlusive footwear. Twice daily application of erythromycin or clindamycin is effective.

Speckled lentiginous nevus

Speckled lentiginous nevus is a patch of hyperpigmentation representing a localized defect in neural crest melanoblasts. Several black or brown macules are seen within a patch of brown hyperpigmentation. Some consider this a variant of Congenital melanocytic naevus.