• Open Access

A cosmetic ‘anti-ageing’ product improves photoaged skin: a double-blind, randomized controlled trial

Authors

  • R.E.B. Watson,

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • S. Ogden,

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • L.F. Cotterell,

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • J.J. Bowden,

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • J.Y. Bastrilles,

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • S.P. Long,

    1. Alliance Boots Ltd, Nottingham NG2 3AA, U.K.
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  • C.E.M. Griffiths

    1. Dermatological Sciences Research Group, School of Translational Medicine, Faculty of Medical and Human Sciences, The University of Manchester, Oxford Road, Manchester M13 9PT, U.K.
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  • Conflicts of interest
    S.P.L. is employed by Alliance Boots Ltd., the manufacturer of the commercially available preparation tested in this study.

  • Re-use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2·5, which does not permit commercial exploitation.

  • Note added after online publication:

    Since the publication of this article online on 28 April 2009, the authors wish to recognize the following changes to the article:

    Title: Effects of a cosmetic ‘anti-ageing’ product on photoaged skin

    Conflicts of Interest: This study was funded by Alliance Boots Ltd.

    Summary

    Methods For the patch test, commercially available test product and its vehicle were applied occluded for 12-days to photoaged forearm skin (= 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, = 30 vs. vehicle, = 30; once daily for 6-months; face & hands) with clinical assessments performed at recruitment and following 1-, 3- & 6-months of use. Twenty-eight subjects had skin biopsies (dorsal wrist) at baseline and at 6 months of treatment for immunohistochemical assessment of fibrillin-1 (test product, = 15; vehicle, = 13). All subjects received test product for a further 6-months. Final clinical assessments were performed at the end of this open period; 27 subjects received test product for 12-months.

    Results In the 12-day patch test assay, we observed significant immunohistological deposition of fibrillin-1 in skin treated by test product and RA as compared to untreated baseline (= 0·005 and 0·015 respectively). In the clinical RCT, at 6 months, compared to baseline assessment, 43% of subjects on test product had an improvement in facial wrinkles (= 0·013), whereas only 22% of subjects using vehicle had clinical improvement (= ns). Between group comparison of test product and vehicle was non-significant (= 0·10). After 12 months, there was a significant benefit of test product over that projected for vehicle (70% vs. 33% of subjects improving; combined Wilcoxon rank tests, = 0·026). There was significant deposition of fibrillin-1 in skin treated for 6 months with test product (mean ± SE; vehicle, 1·84 ± 0·23; test product, 2·57 ± 0·19; = 0·019).

    Conclusion An over-the-counter cosmetic ‘anti-ageing’ product demonstrated clear benefit over vehicle in fibrillin-1 deposition over a 6-month trial period. There was a corresponding but non-significant trend towards clinical improvement in facial wrinkles. Clinical improvements in the treated group were increased after a further 6-months of use. This study demonstrates that a cosmetic may improve the appearance of wrinkles and further supports the use of fibrillin-1 as a robust biomarker for repair of photoaged dermis.

R.E.B. Watson.
E-mail: rachel.watson@manchester.ac.uk

Abstract

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 (= 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, = 15; vehicle, = 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 (= 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, = 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= 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.

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