An “unprecedented” clinical trial on a high street anti-ageing cream may change the face of the skin care market in this country, dermatologists say.At present there is a lack of clinical data to prove which creams really do slow down the skin’s ageing process.

Industry is thought to have shied away from major trials in part for fear products, if effective, could then be deemed medicines and tightly regulated.

But the trial on a Boots moisturiser may prove if these fears are founded.

There was a run on the chain’s No. 7 Protect & Perfect Beauty Serum after the BBC’s Horizon programme last year suggested it might be one of the more effective creams on the market.

“The debate will start on whether there is a point at which a cream is so effective it becomes a medicine”
Professor Chris Griffiths
Manchester University

Chris Griffiths, professor of dermatology at the University of Manchester, has just concluded a clinical trial on the lotion, involving 60 volunteers over a period of six months.

The data is now being analysed before being submitted to a scientific journal for peer review – in what is thought to be an unprecedented process for a high street skin care product.

“If it is proven to work – and there is certainly no guarantee that’s what we’ll find – then the debate will start on whether there is a point at which a cream is so effective it becomes a medicine,” he says.

The active ingredients in the cream include white lupin – a flower extract – and retinyl palmitate, on top of a plain moisturising base. The trial will not establish which, if any, is effective, but how the combination works together.

Rules ‘vague’

If a product is deemed to be a medicine there are significant regulatory implications: it can no longer be sold over the counter and can only be obtained via prescription.

“There are consumers out there who do want the science, but equally there are those who feel it can be a ruse to push prices up”
Chris Flowers
Cosmetics industry

Companies are therefore seen as caught in limbo: keen to prove to consumers their products work but not at the expense of being unable to sell them.

The European regulation which governs UK practice acknowledges that many cosmetic creams do produce an effect but that this needs to be “more than significant” for rules on medicines to kick in.

“This is actually very vague and there is immense room for manoeuvre,” says Dr Richard Weller, a lecturer in dermatology at the University of Edinburgh.

“The public want products which are scientifically proven to reduce wrinkles and the question for the cosmetic world is this: are they prepared to take the risk and take on the regulatory authorities I think they could win.”

Chris Flowers, head of the Cosmetic Toiletry and Perfumery Association (CTPA), said firms did have to walk a”legislative tightrope” when it came to science and regulation but stressed many products already underwent rigorous laboratory testing to validate claims.

“There are consumers out there who do want the science, but equally there are those who feel it can be a ruse to push prices up. We need to cater to both – those who want the extensive trials and those who want a simple product that doesn’t cost the earth.”

In the meantime, and in the absence of major clinical trials, many dermatologists they can safely say benefits the skin is a simple sunscreen