If you’re not living on the edge…
22 February 2010
By Sarah Gregory & Dr Anne Eady
It’s looking like trialling cosmetics in the same way as a drug is the vogue way to give your product competitive edge.
Procter & Gamble is the latest company to undertake a clinical study with one of their anti-wrinkle products that is comparable to tests undertaken by drug companies. The results, published in the scientifically respected British Journal of Dermatology, are impressive showing that the cosmetic product reduces wrinkles to the same extent as a prescription medicine.
There is little doubt that consumers are willing to place their belief in products which are scientifically proven. The Protect & Prefect range at Boots saw huge increases in sales after peer review publication of clinical trial data demonstrating efficacy. This shift in expectation can only be good for both the end user and the industry but are things really that straight forward?
Performing a study on a cosmetic product to the rigour of a medicinal trial is clearly good practice and is to be encouraged. However, many drug trials are badly designed and their results unreliable. Simply doing a drug-type trial on a cosmetic shouldn’t be taken by journalists or the public as an indication of quality or efficacy.
The study performed by Procter and Gamble was not only a good quality trial but also one in which the control arm was a medicinal (drug) product. It was a medicinal trial because it had to be – drugs cannot be compared with cosmetics in a trial performed under the cosmetic regulations. What this high quality trial showed was that a three component cosmetic regimen, of which one component was a retinoid, was at least as effective as a single component prescription product containing a different retinoid. The efficacy of the three component regimen cannot be attributed to the retinoid component. If consumers want to know whether the retinoid available as a cosmetic is as good on its own as the retinoid available on prescription, then another study is required to answer this.
A close call
Wrinkles, the target of the Procter and Gamble product are not a medical indication but a cosmetic one. The company very carefully chose to prove the biological effectiveness of their product by looking at markers of efficacy that lie in the dead cells of the stratum corneum not in the living skin. Thus they have shown that a cosmetic regimen is as good as a prescription medicine but not that the cosmetic works in a pharmacological way that qualifies it for drug status.
More generally, by comparing a cosmetic product with one only available on prescription there is a very real danger of blurring a regulatory line which is already hard to define. A recent New Scientist article gave an overview of some issues which are already muddying the line between cosmetics and medicines and in particular it discusses the Procter and Gamble study.
The New Scientist article points out that if a cosmetic works as well as medicine it could be viewed as a drug in Europe. If cosmetics begin to be tested as drugs and are shown in drug-type trials to be as good as drugs (even if a drug is not included as a comparator), this very finding may challenge their regulatory status as cosmetics.
This increasing regulatory complexity will no doubt be tested over the coming years. Until then exactly what can be claimed by cosmetic products even after they have successfully undergone rigours scientific testing may be a tough judgement call.
Cash to splash
Another issue will almost certainly be the cost of running medicinal quality human use studies with products intended for cosmetic use.
Until now very few cosmetics have been clinically compared to pharmaceuticals or evaluated in randomised controlled trials (RCTs), the gold standard of efficacy testing. Making cosmetic trials as good as pharmaceutical trials can happen without changing the regulatory status of cosmetic products. As long as the comparator is not a medicine, there is no reason why excellent quality studies cannot be performed on cosmetics under the cosmetic regulations. However, RCTs of medicinal quality are costly to set up and run.
In an industry which is largely self-regulated are there many cosmetic companies who would be willing to brave industry regulation at its toughest? Pharmaceutical regulation is notoriously challenging and expensive. Surely there are few cosmetic companies with pockets deep enough to compete on this level?
References
Fu JJJ, Hillebrand GG, Li J, Marmor MJ, Bertucci V, Grimes PE, Mandy SH, Perez MI, Weinkle SH, Kaczvinsky JR. A randomized, controlled comparative study of the wrinkle reduction benefits of a cosmetic niacinamide⁄peptide⁄retinyl propionate product regimen vs. a prescription 0Æ02% tretinoin product regimen. Br J Dermatol. 2010 Feb; 162: 647-654.
Pitman S. Boots beauty sales driven by latest Protect & Perfect launch. Cosmetic Design Europe. Nov 2009.
Watson RE, Ogden S, Cotterell LF, Bowden JJ, Bastrilles JY, Long SP, Griffiths CE. Effects of a cosmetic 'anti-ageing' product improves photoaged skin. Br J Dermatol. 2009 Aug;161(2):419-26.
Geddes L. Anti-ageing cream as good as drug at reducing wrinkles. New Scientist. Feb 2010.
Procter & Gamble is the latest company to undertake a clinical study with one of their anti-wrinkle products that is comparable to tests undertaken by drug companies. The results, published in the scientifically respected British Journal of Dermatology, are impressive showing that the cosmetic product reduces wrinkles to the same extent as a prescription medicine.
There is little doubt that consumers are willing to place their belief in products which are scientifically proven. The Protect & Prefect range at Boots saw huge increases in sales after peer review publication of clinical trial data demonstrating efficacy. This shift in expectation can only be good for both the end user and the industry but are things really that straight forward?
Performing a study on a cosmetic product to the rigour of a medicinal trial is clearly good practice and is to be encouraged. However, many drug trials are badly designed and their results unreliable. Simply doing a drug-type trial on a cosmetic shouldn’t be taken by journalists or the public as an indication of quality or efficacy.
The study performed by Procter and Gamble was not only a good quality trial but also one in which the control arm was a medicinal (drug) product. It was a medicinal trial because it had to be – drugs cannot be compared with cosmetics in a trial performed under the cosmetic regulations. What this high quality trial showed was that a three component cosmetic regimen, of which one component was a retinoid, was at least as effective as a single component prescription product containing a different retinoid. The efficacy of the three component regimen cannot be attributed to the retinoid component. If consumers want to know whether the retinoid available as a cosmetic is as good on its own as the retinoid available on prescription, then another study is required to answer this.
A close call
Wrinkles, the target of the Procter and Gamble product are not a medical indication but a cosmetic one. The company very carefully chose to prove the biological effectiveness of their product by looking at markers of efficacy that lie in the dead cells of the stratum corneum not in the living skin. Thus they have shown that a cosmetic regimen is as good as a prescription medicine but not that the cosmetic works in a pharmacological way that qualifies it for drug status.
More generally, by comparing a cosmetic product with one only available on prescription there is a very real danger of blurring a regulatory line which is already hard to define. A recent New Scientist article gave an overview of some issues which are already muddying the line between cosmetics and medicines and in particular it discusses the Procter and Gamble study.
The New Scientist article points out that if a cosmetic works as well as medicine it could be viewed as a drug in Europe. If cosmetics begin to be tested as drugs and are shown in drug-type trials to be as good as drugs (even if a drug is not included as a comparator), this very finding may challenge their regulatory status as cosmetics.
This increasing regulatory complexity will no doubt be tested over the coming years. Until then exactly what can be claimed by cosmetic products even after they have successfully undergone rigours scientific testing may be a tough judgement call.
Cash to splash
Another issue will almost certainly be the cost of running medicinal quality human use studies with products intended for cosmetic use.
Until now very few cosmetics have been clinically compared to pharmaceuticals or evaluated in randomised controlled trials (RCTs), the gold standard of efficacy testing. Making cosmetic trials as good as pharmaceutical trials can happen without changing the regulatory status of cosmetic products. As long as the comparator is not a medicine, there is no reason why excellent quality studies cannot be performed on cosmetics under the cosmetic regulations. However, RCTs of medicinal quality are costly to set up and run.
In an industry which is largely self-regulated are there many cosmetic companies who would be willing to brave industry regulation at its toughest? Pharmaceutical regulation is notoriously challenging and expensive. Surely there are few cosmetic companies with pockets deep enough to compete on this level?
References
Fu JJJ, Hillebrand GG, Li J, Marmor MJ, Bertucci V, Grimes PE, Mandy SH, Perez MI, Weinkle SH, Kaczvinsky JR. A randomized, controlled comparative study of the wrinkle reduction benefits of a cosmetic niacinamide⁄peptide⁄retinyl propionate product regimen vs. a prescription 0Æ02% tretinoin product regimen. Br J Dermatol. 2010 Feb; 162: 647-654.
Pitman S. Boots beauty sales driven by latest Protect & Perfect launch. Cosmetic Design Europe. Nov 2009.
Watson RE, Ogden S, Cotterell LF, Bowden JJ, Bastrilles JY, Long SP, Griffiths CE. Effects of a cosmetic 'anti-ageing' product improves photoaged skin. Br J Dermatol. 2009 Aug;161(2):419-26.
Geddes L. Anti-ageing cream as good as drug at reducing wrinkles. New Scientist. Feb 2010.