As discussed in my previous blog, Boots had an unprecedented commercial success in Britain in the past few years. The Boots Protect & Perfect serum case gave clear evidence to the skincare industry that a little science could do a lot more for sales than any amount of expensive glossy advertising!
The latest attempt to promote a skincare product through serious scientific scrutiny, this time by Procter & Gamble, hopes to emulate the success of Boots and provide us with a proof of superior efficacy!
This month the British Journal of Dermatology will publish a scientific study showing that an anti-ageing cream, Olay Pro-X, is as efficacious at reducing wrinkles as a prescription-only treatment. In the study, 99 women who applied the Olay product several times a day for six months were compared to other 97 women receiving prescription-only retinoid treatment with well-known efficacy. Wrinkle reduction was assessed by grading on high-resolution digital images at eight and 24 weeks into the trial and showed that an appropriately designed cosmetic regimen can improve facial wrinkle appearance comparably with the benchmark prescription treatment and without its side effects.
P&G plans to launch Olay Pro-X in Britain next year! And the active ingredients look great – more about them in my next blog.
It is interesting how science translates into our daily routines.. Sometimes serendipity rules what we buy!
The Power of the Media
It all started, at least for us, the consumers, with the BBC Horizon Professor Reagan’s Beauty Parlour programme run on 27th March 2007. The Boots No7’s Protect & Perfect Beauty Serum was shown to be as effective in anti-ageing as prescription-only products. At the time, the 30 ml serum tube was selling at £16.75.
The next day, consumer demand was so huge it made the national news! Rumour has it that it caught Boots unprepared and over 17,000 customers logged onto the waiting list. But the commercial success that followed was phenomenal! 13 products sold every minute (making over 7.8 million in the first year), it even commanded up to £100 on Ebay. Awarded the 2008/2009 Product of the Year, there is a good chance you bought it too, persuaded by the science!
The Real Science Behind the Serum
Over a year later, in March 2008, a scientific paper was published in the British Journal of Dermatology by Boots and Manchester University that gave us the details of the study. What was not necessarily understood before was that the method – used to establish whether the serum had the ability to repair sun-damaged skin – was an occlusive (closed) patch worn for 12 days on the forearm. Carried out on nine volunteers, the serum was compared to the gold standard in dermal repair, retinoic acid.
The patch-test study showed that the formulation with 6% of active complex (which contains lipopentapeptide, white lupin peptides, antioxidants and retinyl palmitate) increased the deposition of two dermal proteins (fibrillin-1 and pro-collagen I) – a result superior to the retinoic acid. The Manchester research group concluded that the serum can induce changes in sun-damaged skin that are indicative of dermal repair.
However, although the result is positive, the testing method does not resemble the way we use facial skincare, the so called “in-use conditions”. Our facial skin is different to our forearm and we don’t walk around with plastic bags on our faces!
The Long-Awaited Clinical Trial
With this dream product endorsement – even more powerful than advertising – Boots started a six month long clinical trial. They had to make sure that women will see clinically relevant and visible results and changed the original to a new formulation – previously Refine & Rewind, now marketed as the Protect & Perfect Intense Beauty Serum.
First, the patch-test was repeated with the new formulation on the sun-damaged forearm of 10 volunteers. After that, a rigorous 6-month trial (double-blind, randomized, controlled) was carried out in 60 volunteers (11 men, 49 women, age range 45 – 60 years), who applied the new serum to their face once a day in the evening. Half a year in, there were some clinical improvements – 43 % of volunteers using the new serum showed improvement in facial wrinkles compared to 22 % of women using a placebo (the same formulation without the active ingredients). But the comparison between the new serum and placebo group was not statistically significant – a result that is somewhat disappointing! The new serum showed statistically significant improvement compared to the baseline (at the start of the clinical trial). Both the new serum and placebo improved skin texture to a similar degree and neither had an impact on skin pigmentation.
A good statistician would tell you that extending a clinical trial in this fashion is not the best practice. But Boots did extend with a further 6-month open phase. All volunteers were now using the new serum for another 6 months (and the placebo response was extrapolated at 12 months by statistical simulation).
So, after a year, Boots showed the new serum having clinically visible and statistically significant benefit: 70 % of volunteers improved their facial wrinkles (compared to 33 % using placebo as extrapolated)!
To sum it up: Very few cosmetic anti-ageing products have their efficacy tested in a rigorous double-blind, controlled clinical trial. So, it is a benchmarking clinical study - but is it really the best product on the market? The only reliable evidence as to the effect of the new serum is at the end of the first 6 months – and that’s not brilliant.
Boots advertise it as “Our most effective anti-ageing product ever” but would not any well-formulated product with a similar level of anti-ageing ingredients perform as well if not better? The interesting thing is that the Manchester group behind this research has published a paper “Evidence for an ‘anti-ageing’ product may not be so clear as it appears”, coming out in November – we certainly have to wait and see!
Sources: http://www.bbc.co.uk/sn/tvradio/programmes/horizon/broadband/tx/beautyparlour/; http://www.guardian.co.uk/lifeandstyle/2007/may/03/shopping.science; http://www.clickpress.com/releases/Detailed/63616005cp.shtml