Effects of a cosmetic 'anti-ageing' product improves photoaged skin [corrected]: a double‐blind, randomized controlled trial

Methods For the patch test, 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 & 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, n = 15; vehicle, n = 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 (P = 0Æ005 and 0Æ015 respectively). In the clinical RCT, at 6 months, compared to baseline assessment, 43% of subjects on test product had an improvement in facial wrinkles (P = 0Æ013), whereas only 22% of subjects using vehicle had clinical improvement (P = ns). Between group comparison of test product and vehicle was non-significant (P = 0Æ10). 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, P = 0Æ026). There was significant deposition of fibrillin-1 in skin treated for 6 months with test product (mean ± SE; vehicle, 1Æ84 ± 0Æ23; test product, 2Æ57 ± 0Æ19; P = 0Æ019). 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.