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

Disclosures

The British Journal of Dermatology. 2009;161(2):419-426. 

In This Article

Summary and Introduction

Summary

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.

Introduction

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.[1] 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.[4] Photoaged skin has a different ECM morphology with solar elastosis—the deposition of dystrophic elastic fibres in the dermis—being a prominent histological feature.[5] Photoaged dermis contains significantly reduced levels of collagen types I and III,[6] fewer anchoring fibrils at the dermal–epidermal junction (DEJ; collagen VII)[7] and loss of the fibrillin-rich microfibrillar architecture in the papillary dermis.[8] 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.[12] 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[13] and VII[14] and restoration of the fibrillin-rich microfibrillar network.[15] 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.[19]

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.

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