Inter-Toe Cracks: A Cosmetic Response versus Excipient. Efficacy and Tolerance Evaluation

Abstract

A randomized, monocentric, double-blind, intra-individual excipient-controlled comparative study was performed to evaluate the efficacy and tolerance of an active peptide (laminin 5 fragment [LN-5]) formulated in cosmetic balm, versus excipient in inter-toe cracks. Two products were tested on 10 healthy volunteers. Each of them suffered from this particular superficial wound characterized by a peeling off a skin tab between at least two inter-toe spaces. The duration of this study belonged of 28 days with an intermediate visit to D14. Initial and outcome evaluation was performed using a 4-grade-scale depending on the severity of the inter-toe cracks. Tolerance and healing were assessed using macrophotographs. At D14 and D 28, the difference of cure between the 2 treatments was in favor of the peptide active product. The clinical score showed a best efficiency of the active compared with the excipient; indeed a significant difference between D28 and D0 was observed for the active ingredient. Active product repairs more quickly inter-toes cracks than the excipient and we noted the complete disappearance of the “severe” and “moderate” stages from the 14 th day. This study showed clearly a fast (in 14 days) and beneficial effect of the application of LN-5 compared with the excipient, on the cutaneous repair of inter-toes cracks. Since LN-5 fragment is capable of producing immediate biological activity and reinforcing the dermal-epidermal junction, it can accelerate tissue repair.