TRYING to hold back the ravages of time is an expensive business. People around the world spend a staggering $290 billion a year on over-the-counter beauty products. Cosmetics companies invest a fortune 鈥� around 2 per cent of their sales 鈥� on researching and developing new products.
These ample budgets mean cosmetic houses are able to employ some very capable scientists who perform high-quality research. In areas such as the biology of the outermost layer of skin they are world leaders. Yet despite all this activity, we know next to nothing about whether the anti-wrinkle creams they produce actually work. Do they do any more than temporarily hydrate and plump up the skin?
Anti-ageing products may be marketed with slogans such as 鈥渋mproves the appearance of wrinkles鈥�, but cosmetics companies release very little in the way of trial data. In medical practice, the gold standard for proof of persistent benefit to a patient is the double-blind randomised controlled trial (RCT), published in a peer-reviewed journal. So why do we not see such a well-established methodology used for cosmetics?
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The industry faces a dilemma. If a rigorous trial of an anti-ageing cream showed no benefit, no one would buy it. Yet if it really does produce structural changes and permanently reduces wrinkles, the cream could be reclassified as a pharmaceutical agent 鈥� which would mean it could no longer be sold to the public unless prescribed by a doctor.
鈥淪ome products now sold as cosmetics might have to be reclassified as medicines鈥�
Clinically proven treatments to reduce wrinkling and the pigment changes caused by sun damage do exist. For instance, products containing retinoic acid have been available for a couple of decades, and robust trials have confirmed that they improve the appearance of sun-damaged skin and stimulate new collagen growth in the dermis; however, side effects such as skin irritation mean these products are only available on prescription. In contrast, strong evidence in favour of over-the-counter anti-ageing products has been elusive.
This may be about to change. Last year, a group led by , UK, carried out what is thought to be the first ever rigorous independent test on an over-the-counter anti-ageing product. The team compared the performance of Protect and Perfect, manufactured by the health and beauty company Boots, with retinoic acid and a moisturiser control. The study was reported by the BBC TV Horizon programme and, more importantly, published in a peer-reviewed journal this March .
The researchers applied the three preparations to the sun-damaged skin of volunteers over 12 days, and took biopsies from the treated sites and from a control site. To the surprise of the investigators, the cosmetic proved almost as effective as retinoic acid in repairing sun-damaged skin. Even more striking was the buying frenzy that followed. Within an hour of opening, most .
This trial was not the gold-standard RCT, so the same researchers embarked on a six-month double-blind clinical trial, now nearing completion. There is huge interest in the outcome, as it could change the public鈥檚 expectations of cosmetic testing.
In particular, it could mean that some products now sold as cosmetics will have to be reclassified as medicines. This is a notoriously tricky area. The European regulations acknowledge that 鈥渁lmost every product usually perceived as a cosmetic鈥� does in some way or another, modify physiological function鈥�. But they add that 鈥渢he modification has to be more than insignificant鈥� for it to be treated as a medicine.
Many substances we apply to our skin modify it. Sunblock, for instance, significantly alters our response to UV, immunologically and structurally, but suncreens are not classed as medicines. Other products commonly found in cosmetics such as glycols, alpha-hydroxy acids and ceramides all produce changes in the epidermis that are considered to be within the 鈥渃osmetic鈥� range of effects. In such a grey area, decisions inevitably have to be made on a case-by-case basis.
Until a year ago, Protect and Perfect was unequivocally a cosmetic. Will this change if the forthcoming trial results show a clinical reduction in wrinkles as well as evidence of repair of sun damaged skin? It seems unlikely that a cosmetic will retrospectively be reclassified as a pharmaceutical, so this trial could be a wake-up call for the cosmetic industry to prove that its products actually work.
The reaction to Griffiths鈥檚 trial shows there is an enormous pent-up desire for some hard, independent clinical proof of the effectiveness of the cosmetics we can buy. I suspect that those companies that take the risk and prove the effectiveness of their anti-ageing products can only benefit in the long term.
After all, you鈥檙e worth it, so shouldn鈥檛 you expect real data?