Assessment of wound healing efficacy and tolerability using CicatrylTMcream based on a suction blister model in healthy subjects

Abstract

CicatrylTMcream, a topical medical device, is indicated for the treatment of superficial wounds and small skin injuries. To assess the efficacy and tolerability of CicatrylTMcream by measuring the recovery of the skin barrier after inducing wounds. A suction blister of about 6-mm diameter was induced on the inner side of each forearm of 44 healthy subjects. Using a process of randomisation, CicatrylTMcream was then applied to one wound for a maximum duration of 14 days, while the other wound was left untreated. The primary objective was to evaluate the effect of the test product on wound healing at Day 6, by comparing treated versus untreated wound areas measured by macrophotography. Secondary objectives were to evaluate healing, cutaneous barrier restoration and subjective efficacy of the cream as well as tolerability. The mean wound area (± SD) at Day 6 was significantly smaller for treated wounds compared with untreated wounds (1.76±4.71 vs 15.76±7.61 mm2; p < 0.0001). For treated wounds, wound healing between Days 1 and 6 was 1.6-fold faster compared with untreated wounds (-7.90 vs-4.79 mm2/day; p < 0.0001), and the wounds healed in approximately half the time (6.8 vs 12.2 days for untreated wounds). Cutaneous barrier restoration occurred earlier for treated wounds (Day 6 vs Day 8 for untreated wounds). The cream was well tolerated, and no serious adverse events were observed. CicatrylTMcream improves wound healing, especially within the first six days, if applied in accordance with the manufacturer's instructions.