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A cosmetic ‘anti‐ageing’ product improves photoaged skin: a double‐blind, randomized controlled trial
Author(s) -
Watson R.E.B.,
Ogden S.,
Cotterell L.F.,
Bowden J.J.,
Bastrilles J.Y.,
Long S.P.,
Griffiths C.E.M.
Publication year - 2009
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2009.09216.x
Subject(s) - watson , medicine , scholarship , randomized controlled trial , surgery , political science , computer science , natural language processing , law
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.