We show here, for the first time, that a commercially available over-the-counter ‘anti-ageing’ product improves the appearance of facial wrinkles when used in the long term. This improvement is associated with restoration of fibrillin-1, the major component of fibrillin-rich microfibrils, in product-treated skin.
In these studies, we performed a double-blind RCT to assess whether or not an over-the-counter cosmetic ‘anti-ageing’ product can produce clinically significant improvement in the appearance of photoaged facial skin. The trial was executed to the highest standards, with study creams coded and randomized at source, and with the volunteers, investigators and independent statistician ‘blind’ to the coding until after study completion and initial data analysis. We did not observe any benefit of the vehicle or test product on the appearance of mottled dyspigmentation or actinic lentigines associated with photoageing. Expert clinical assessments (S.O., J.Y.B.) showed that subjects treated with the vehicle formulation had improved skin texture compared with that observed at their recruitment, but did not exhibit any change in the appearance of their facial wrinkles. Those treated with the test product showed improvements in both skin texture (compared with their baseline clinical assessment) and, more importantly, in the appearance of facial wrinkles. This improvement in the appearance of facial wrinkles became significant only after 12 months of daily product use comparing between groups. It is interesting to note, however, that when compared with the baseline, the test product did lead to a noticeable clinical improvement in facial wrinkles (P = 0·013) in 43% of treated individuals after 6 months, compared with only 22% of those treated with the vehicle where there was no significant improvement in appearance (P = 0·11). In a comparison between groups, this improvement was not statistically significant but does indicate that larger clinical trials of cosmetic products might be expected to show useful clinical improvement after 6 months’ use. The data from this study are indicative that cosmetic ‘anti-ageing’ products can result in noticeable clinical improvement in facial wrinkles. To our knowledge, this is the first time such benefits have been reported for a commercially available cosmetic ‘anti-ageing’ product and paves the way for larger studies with more statistical power.
In addition, we examined the distribution of a key biomarker of photoageing—loss of fibrillin-1 in the papillary dermis—in skin samples obtained during the RCT. Fibrillin-1 is the major glycoprotein component of fibrillin-rich microfibrils (oxytalan fibres). Skin treated with the test product contained significantly more fibrillin-rich microfibrils in the papillary dermis than either the baseline samples or those treated with the vehicle (P
=0·019). Our previous research, which demonstrated that an over-the-counter cosmetic ‘anti-ageing’ product can bring about increased fibrillin-1 deposition in the papillary dermis, used a short-term, exaggerated-use patch test assay.19
In the current study, we sought to determine whether results obtained using such an experimental system were predictive of clinical improvement following long-term use of such a product.
Consumers purchasing cosmetic skin care products—particularly those purporting ‘anti-ageing’ properties—are presented with a broad choice of available products and only limited data regarding their efficacy. The situation is further complicated for consumers by the use of trademarked proprietary names for ingredients and the relative lack of published long-term studies to demonstrate product performance. We previously sought to investigate if a cosmetic ‘anti-ageing’ product can have a measurable effect on fibrillin-1 and established that histological improvement could be achieved in a short-term exaggerated-use assay.19
The results from that study were indicative of some degree of structural change in the skin following use of a cosmetic but provided no evidence for actual clinical improvement. To address this question, the current study compared the use of a commercially available cosmetic ‘anti-ageing’ skincare serum to its vehicle and has shown that such a product is capable of bringing about a clinical improvement in the appearance of photoaged skin when used for 12 months.
The difference in efficacy between the vehicle and the test product demonstrates that a correctly formulated skincare product can deliver clinically relevant skin improvement, above that delivered by the vehicle base. The studied product contains the retinol ester, retinyl palmitate, together with natural plant extracts, peptides and lipopeptides and antioxidants. Other authors have shown evidence for the role of many of these cosmetic ingredients in protecting against mechanisms that lead to dermal degradation, such as increased MMP activity22
and stimulating repair of dermal components.23–25
It was our belief that a combination of ingredients with activities known to address the multiple changes which occur in photoaged skin (degradation of collagen and elastin, the appearance of surface wrinkling and textural changes) may be beneficial in a cosmetic product when used long term. Specifically, the retinyl palmitate, palmitoyl peptides and Medicago sativa
extracts have been shown in vitro
to lead to deposition of collagen 1 in model skin systems and the extract of white lupin has been shown to inhibit MMP-1 (S.P. Long, unpublished data). In our previous study using the 12-day assay, a similar product induced deposition of pCI as well as fibrillin, together with inhibition of MMPs.19
These data suggest that the long-term benefits described here may be due to a combination of actions. The product does not contain sunscreens, so the visible skin improvements cannot be attributed to photoprotection of the skin. Further work is underway to elucidate the relative contributions of the individual ingredients.
The finding that a clinically relevant improvement in the appearance of photoaged skin was demonstrated with long-term use of a commercially available cosmetic ‘anti-ageing’ product may cause some to question whether such effects are within the definition of a cosmetic. Improvement in the appearance of wrinkles is considered to be a cosmetic action, as the effect is localized to the skin and is not concerned with treatment or correction of a disease condition. Several other authors report that application of cosmetic products leads to changes in skin physiology, including changes in barrier function,26,27
stratum corneum thickness28
and that cumulative effects of cosmetic products are possible, a principle demonstrated for skin moisturization30
and recognized by regulatory authorities.31
When compared with the long-term clinical effects of topical RA, it can be seen that the degree of improvement offered by a cosmetic product is still markedly less than that which is achievable with a prescribed medicine.32–38
In conclusion, these studies provide evidence that use of an over-the-counter cosmetic ‘anti-ageing’ product is able to induce clinically identifiable improvement in the appearance of facial wrinkles following long-term use. This improvement is associated with deposition of fibrillin-rich microfibrils in the papillary dermis of treated skin. The study further supports the use of fibrillin-1 in a short-term assay as a biomarker for assessing efficacy of potential photoageing repair products.