A Novel Sequential Multi-tiered In-vivo Approach For Quantitative Evaluation Of Topicals For Treatment Of Human Skin Scarring
Rubinder Basson1, Martin Isabelle2, David Reece2, Philip Foden3, Mohamed Baguneid3, Ardeshir Bayat1
1University of Manchester, Manchester, United Kingdom, 2Renishaw, Gloucestershire, United Kingdom, 3Manchester University NHS Foundation Trust, Manchester, United Kingdom
BACKGROUND Despite the abundance of topical formulations on the market for cutaneous wound and scar management, there are few with high levels of evidence. This is compounded by a relative paucity of methods for objective and quantitative evaluation of their effect in human skin. We propose a novel, multi-tiered approach for the evaluation of a topical, in particular one with an unknown mechanism of action.
METHODS A randomised, blinded, clinical trial with 45 human participants compared an ‘active’ topical against a placebo over 16 weeks. Skin scarring was created using a 5mm biopsy punch to the upper arms and both topicals applied. Participants then received sequential biopsies of each scar. Non-invasive quantitative measurements were taken biweekly and the results validated by gene and protein studies.
RESULTS This multi-tiered approach allowed for evaluation of the topical by analysing its effect on three functional parameters of skin scarring: (1) structure, (2) physiology, and (3) mechanical features. Structurally, non-invasive measurements showed an improvement in pigmentation by week 12 (W12) (p=0.025) by the active topical. Physiological assessment of the skin barrier showed an increase in hydration (p<0.05) which was validated by immunohistochemical analysis of hyaluronic acid at sequential time points, (W4 p=0.014, W8 p=0.039, and W12 p=0.042). Within mechanical parameters, elasticity was increased at W16 (p=0.009), validated by increased elastin (p=0.044) and fibronectin (W4 p=0.009, W8 p=0.038, and W16 p=0.026) levels. To detect the presence of topical within the scar tissue; Raman spectroscopy was used, which showed penetration of the topical through the scar, in the epidermis, and deep in the reticular layer.
CONCLUSIONS We demonstrate for the first time, a quantitative analysis of the effect and presence of a topical in early cutaneous scar maturation over progressive sequential time points. This approach supports objective evaluation of newly emerging topicals in wound and scar management.
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