An online product page for a laser skin device on the website www.johnlewis.com stated "It stimulates your skin's natural cell renewal process, targeting several signs of ageing. With visible results you can really see and feel over the 8-week course of treatment, Dermatologists confirm that the Phillips ReAura stimulates the production of collagen to reduce fine lines around the eyes and mouth and on the cheeks. A more even skin tone is achieved and age spots and sunspot are visibly diminished. Cell renewal is encouraged in the deeper layers of the skin for smoother skin texture ... Old and damaged skin cells are replaced with new, fresh skin cells, containing more collagen. Repeated treatments boost the collagen network, making it denser. The result is a smoother skin texture and the reduction of fine lines. At the same time, pigmented skin cells are pushed out of the skin. This gives your skin a more even tone ... The laser aftercare complex contains calming chamomile as well as St John's Wort and edelweiss extracts, which are known for their anti-inflammatory properties".
The complainant challenged whether the efficacy claims for the laser product were misleading and could be substantiated.
John Lewis Partnership plc believed the efficacy claims for the product could be substantiated by the 2010 trial which they supplied. They said the trial showed that following treatment, the subjects underwent independent evaluator assessments which they believed demonstrated a positive treatment effect after the initial eight-week period. They said the trial showed the best results were in overall appearance and pigmentation (most noticeable after 12 weeks of treatment) and that in the other investigated areas such as fine lines, texture, skin radiancy and skin firmness, there were reported improvements.
The ASA asked an expert to examine the evidence provided in support of the efficacy claims for the product. We noted the trial was intended to examine the safety of the product alongside efficacy, but the expert noted it was not placebo controlled and that there was no (non-placebo) control group in order to demonstrate that any reported results could be attributed directly to the product. Whilst it was acknowledged that it was difficult to create a placebo for a laser product, it was noted by the expert that it was not impossible. It was further noted that the trial could have been conducted using a randomised half face design (treatment vs no treatment) which could have provided both a control and more statistical power. The expert further noted that some of the measures examined in the trial (such as fine lines and wrinkles, dyschromia and texture) could reasonably be expected to change with fading baseline skin pigmentation through the period of October to July. Whilst the expert acknowledged it was not possible to say how much, if at all, this would have changed the results, the lack of control or untreated group meant that this had not been assessed or subtracted from any produced effect.
In addition, it was noted the trial required that participants used a tracking gel to help the product glide across the skin. The expert noted additional information supplied about the composition of the tracking gel showed that it contained 7.75% glycerine and 54% caprylic/capric triglycerides, both of which would have a measureable effect on skin properties and appearance both immediately and cumulatively. We therefore considered that the trial did not demonstrate that the reported effects could not be attributed (wholly or in part) to that gel. Furthermore, although test subjects were asked to remove traces of skin products (including moisturisers) prior to each treatment, it did not require that all subjects cease their normal skin care routine (or prevent them from adding to their routine following treatment) and therefore it was not possible to demonstrate that any reported changes were attributable to the product itself and not because of any other factors.
With regard to the results, the expert noted there were statistically significant differences in the results which were not explained. It was also noted that during the period of the product testing, self-reporting and blind assessors reported various levels of improvement in overall appearance, skin pigmentation, dyschromia, fine lines and wrinkles and texture. It was noted however that ‘blind’ assessors reported no significant changes across the trial and also reported that all changes that had occurred returned to the baseline three months after the last treatment, which indicated that either there was no permanent change in skin structure or that the product had to be used continuously in order to maintain the temporary nature of the effect. Furthermore, it was noted one of the trials specifically stated that independent assessment of photographs from the baseline showed there was no significant decrease in lines and wrinkles.
Our expert was therefore concerned that even if it could be concluded that there was a benefit from using the laser device without the accompanying tracking gel, the trial itself was not sufficiently robust to prove the efficacy of the product.
Finally, with regard to the histology results examining the collagen levels, although the biopsies from ten of the trial subjects were considered likely to be a large enough number to show dermal results, the expert noted the number of pictures presented were not of sufficient number to show those results were representative of the whole study.
Our expert was therefore concerned that the design and presentation of the histology data were not sufficiently robust to support the efficacy claims with regard to collagen.
Because of the concerns about the robustness of the trial evidence we considered that the efficacy claims for the product had not been substantiated and therefore concluded that the ad was misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means. (Misleading advertising). 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation) and 12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The ad should not appear again in its current form. We told John Lewis Partnership to ensure it held robust evidence before making efficacy claims in the future.