Here's the link to that study on the Boot's Number 7 Intense Serum: http://www.medscape.com/viewarticle/708325
Here are the basics - the actualy study info is too long to post - see the link if you want to read the whole thing and see the pictures.
From The British Journal of Dermatology
A Cosmetic 'Anti-ageing' Product Improves Photoaged Skin: A Double-blind, Randomized Controlled Trial
R.E.B. Watson; S. Ogden; L.F. Cotterell; J.J. Bowden; J.Y. Bastrilles; S.P. Long; C.E.M. Griffiths
Posted: 09/24/2009; The British Journal of Dermatology. 2009;161(2):419-426. © 2009 Blackwell Publishing
Summary and Introduction
Background: Very few over-the-counter cosmetic 'anti-ageing' products have been subjected to a rigorous double-blind, vehicle-controlled trial of efficacy. Previously we have shown that application of a cosmetic 'anti-ageing' product to photoaged skin under occlusion for 12 days can stimulate the deposition of fibrillin-1. This observation infers potential to repair and perhaps clinically improve photoaged skin.
Objective: We examined another similar over-the-counter cosmetic 'anti-ageing' product using both the patch test assay and a 6-month double-blind, randomized controlled trial (RCT), with a further 6-month open phase to assess clinical efficacy in photoaged skin.
Methods: For the patch test, a commercially available test product and its vehicle were applied occluded for 12 days to photoaged forearm skin (n = 10) prior to biopsy and immunohistochemical assessment of fibrillin-1; all-trans retinoic acid (RA) was used as a positive control. Sixty photoaged subjects were recruited to the RCT (test product, n = 30 vs. vehicle, n = 30; once daily for 6 months, face and hands) with clinical assessments performed at recruitment and following 1, 3 and 6 months of use. Twenty-eight volunteers had skin biopsies (dorsal wrist) at baseline and at 6 months treatment for immunohistochemical assessment of fibrillin-1 (test product, n = 15; vehicle, n = 13). All volunteers received the test product for a further 6 months. Final clinical assessments were performed at the end of this open period.
Results: In the 12-day patch test assay, we observed significant immunohistological deposition of fibrillin-1 in skin treated with the test product and RA compared with the untreated baseline (P = 0·005 and 0·015, respectively). In the clinical RCT, at 6 months, the test product produced statistically significant improvement in facial wrinkles as compared to baseline assessment (P = 0·013), whereas vehicle-treated skin was not significantly improved (P = 0·11). After 12 months, there was a significant benefit of the test product over that projected for the vehicle (70% vs. 33% of subjects improving; combined Wilcoxon rank tests, P = 0·026). There was significant deposition of fibrillin-1 in skin treated for 6 months with the test product [(mean ± SE) vehicle 1·84 ± 0·23; test product 2·57 ± 0·19; ANCOVA P = 0·019).
Conclusions: In a double-blind RCT, an over-the-counter cosmetic 'anti-ageing' product resulted in significant clinical improvement in facial wrinkles, which was associated with fibrillin-1 deposition in treated skin. This study demonstrates that a cosmetic product can produce significant improvement in the appearance of wrinkles and further supports the use of fibrillin-1 as a robust biomarker for the repair of photoaged dermis.
All tissues, regardless of body site, are subject to intrinsic ageing, the result of the passage of time. Few clinically apparent changes occur in intrinsically aged skin until the individual is over 70 years of age at which point fine wrinkles become apparent. Skin, more than any other organ, is also subject to environmental influences which can lead to extrinsic ageing. One such environmental factor is chronic exposure to sunlight which results in phenotypic changes termed photoageing—inevitably a combination of intrinsic ageing and photodamage. By comparison with intrinsic ageing, photoaged skin is rough, dyspigmented and exhibits both fine and deep wrinkles.[2,3] Histological examination of intrinsically aged skin reveals atrophy of the dermal extracellular matrix (ECM), with reduced levels of collagen and elastin. Photoaged skin has a different ECM morphology with solar elastosis—the deposition of dystrophic elastic fibres in the dermis—being a prominent histological feature. Photoaged dermis contains significantly reduced levels of collagen types I and III, fewer anchoring fibrils at the dermal–epidermal junction (DEJ; collagen VII) and loss of the fibrillin-rich microfibrillar architecture in the papillary dermis. These remodelled ageing phenotypes are thought in part to be due to increased cutaneous expression of matrix metalloproteinases (MMPs).[9–11]
Topical retinoids are used as the clinical, evidence-based 'gold standard' for the treatment of photoaged skin. Numerous studies have shown the reparative effects of topical application of all-trans retinoic acid (RA), which includes the partial restoration of collagens I, III and VII and restoration of the fibrillin-rich microfibrillar network. These ECM changes, together with reduced MMP expression may in part explain the clinical improvement of photoaged skin produced by topical retinoids.[16–18] We showed previously, in a 12-day occluded patch test assay, that a specific cosmetic 'anti-ageing' product also has the ability to stimulate the accumulation of fibrillin-1.
Although prescription retinoids can affect these significant clinical and histological changes in photoaged skin there is scant evidence that any of the plethora of cosmetic 'anti-ageing' products can produce similar effects. We firstly examined whether another, similar cosmetic 'anti-ageing' product can induce accumulation of fibrillin-1 in photoaged skin using the patch test protocol. We then investigated the same product in a rigorous double-blind, randomized controlled trial (RCT) to ascertain whether or not its use results in a clinically detectable benefit.
A commercially available product provided by Alliance Boots Ltd (No7 Protect & Perfect Intense Beauty Serum™ Alliance Boots Ltd
, Nottingham, UK) was investigated in these studies, together with a vehicle formulation. The product is a water in silicone emulsion with glycerine and other emollients and a complex of 'anti-ageing' ingredients comprising natural extracts and peptides: sodium ascorbyl phosphate, Panax ginseng, Morus alba, Lupinus alba, tocopherol, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, Medicago sativa and retinyl palmitate. The vehicle was of identical composition, but without the complex of 'anti-ageing' ingredients.
Randomized Controlled Trial
Clinical Assessment At 6 months, the test product produced statistically significant improvement in facial wrinkles as compared to baseline assessment (P = 0·013), whereas vehicle-treated skin was not significantly improved (P = 0·11). 43% of the subjects who had received the test product showed an improvement in facial wrinkles compared with the baseline assessment, whereas only 22% of the subjects receiving the vehicle showed improvement compared with baseline (Fig. 2). Use of the test product produced a clinically significant improvement in facial wrinkles after 12 months of use, with a statistically significant between-groups benefit of test product vs. the vehicle (test product, 70% of subjects improving compared with vehicle, 33% improving; combined Wilcoxon rank tests, P = 0·026) (Fig. 2). No benefits of the test product were seen for improvement in mottled dyspigmentation. Use of either formulation produced an improvement in skin texture over that recorded at baseline (vehicle, P = 0·001; test product, P = 0·001), but the test formulation did not perform significantly better than the vehicle (data not shown; P = 0·72).
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.
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. 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 activity 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. 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 thickness and lipidogenesis and that cumulative effects of cosmetic products are possible, a principle demonstrated for skin moisturization and recognized by regulatory authorities. 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.